Intouch
5 catalogue numbers from 2141-PX3-000, listed by Stryker GmbH, Switzerland, under Bed, Ac-Powered Adjustable Hospital. 95 manufacturers in China are registered for this product code.
95manufacturers in China registered for this device type
5catalogue numbers in this listing
6510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (32), Jiangsu (20), Hebei (11). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Genteel Homecare Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 12 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Jiaxing Kalanchoe Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 8 |
| Jiangmen Jia Mei Medical Products Co., Ltd. | Heshan | Guangdong | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 95. All 95 manufacturers in China registered for Bed, Ac-Powered Adjustable Hospital
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FNL |
| Device type | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Handling environment temperature -40 to 158 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 158 °F; Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2141-PX3-000 | In distribution | |
| 2141 | In distribution | |
| 2131 | In distribution | |
| 2141 | In distribution | |
| 2131-PX1-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drive | Drive DeVilbiss Healthcare | 190 |
| Electrical Hospital Bed | Paramount BED Co., Ltd. | 164 |
| MC Healthcare | Span-America Medical Systems, Inc. | 160 |
| NOA Medical Industries, Inc. | Hoffmann NOA Medical Industries, LLC | 99 |
| Posey | Posey Products, LLC | 95 |
| Drivemedical | Drive DeVilbiss Healthcare | 94 |
| Enterprise | Arjohuntleigh AB | 80 |
| silverfox | Silverfox Corporation Limited | 77 |
| Electrical Hospital Bed with Digital Scale | Paramount BED Co., Ltd. | 70 |
| Basic American Medical Products | GF Health Products, Inc | 66 |
| Bed, Ac-Powered Adjustable Hospital | Gendron, Inc. | 50 |
| Accessories | Joerns Healthcare | 43 |
Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202964 | 2021-06-18 |
| K103536 | 2010-12-16 |
| K946149 | 1995-03-14 |
| K931482 | 1993-09-09 |
| K875037 | 1988-02-11 |
| K852674 | 1985-07-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker GmbH | UDI-DI | 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 2 units |
Recalls
34 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2023-08-30 | Class II | Process control | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | ||
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 9 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 4 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 33 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 21 units | |
| 2018-10-08 | Class II | Device Design | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment. | 2020-04-28 | |
| 2018-10-08 | Class II | Device Design | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment. | 20,030 total | 2020-04-28 |
| 2016-02-02 | Class II | Component change control | CPU board failures cause fowler (backrest) electronic controls to stop working. | 8490 | 2017-06-12 |
| 2015-07-02 | Class II | Device Design | Customer complaints associated with faulty brake system | 143 total | 2017-03-24 |
| 2015-07-02 | Class II | Device Design | Inaccurate scale systems | 143 | 2017-03-24 |
| 2014-06-04 | Class II | Device Design | Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster | 11,632 units | 2016-03-14 |
| 2013-11-26 | Class II | Device Design | Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power | 108,769 Total | 2015-05-29 |
| 2013-11-26 | Class II | Device Design | Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power | 108,769 Total | 2015-05-29 |
| 2013-10-23 | Class II | Equipment maintenance | It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. A | 4126 units USA; 20449 inits Internationally | 2014-05-16 |
| 2013-08-19 | Class II | Device Design | The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged. | 61 units | 2014-01-29 |
| 2012-12-18 | Class II | Process control | Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. | 1004 | 2013-08-30 |
| 2012-12-18 | Class II | Process control | Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the bra | 9 | 2013-08-30 |
| 2012-05-17 | Class II | Component design/selection | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed | 8009 | 2014-05-12 |
| 2012-05-17 | Class II | Component design/selection | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed | 6325 | 2014-05-12 |
| 2012-05-17 | Class II | Component design/selection | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed | 9440 | 2014-05-12 |
| 2012-05-17 | Class II | Component design/selection | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed | 999 | 2014-05-12 |
| 2012-05-17 | Class II | Component design/selection | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed | 2546 | 2014-05-12 |
| 2012-03-12 | Not classified | Component change control | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may | 58474 | 2013-08-29 |
| 2012-03-12 | Not classified | Component change control | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may | 467 | 2013-08-29 |
| 2012-03-12 | Not classified | Component change control | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may | 4060 | 2013-08-29 |
| 2012-03-12 | Not classified | Component change control | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may | 507 | 2013-08-29 |
| 2012-03-12 | Not classified | Component change control | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may | 58474 | 2013-08-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.