Sterilizer, Steam
The Atlas Transfer Carriage, Painted Carbon Steel 26-inch, x 37.5-inch, x 54-inch is designed for use with sterilization systems.
3manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Steris Mexico, S. de R.L. de C.V., Mexico |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K091136 |
| Record published | 2019-08-19 |
| Record revised | 2023-06-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Sizes | Width 20 to 51 in; length 36 to 66 in; height 20 to 37.5 in |
| Distribution end date | 2020-10-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15091-12 | In distribution | |
| FV021005 | Length 38 in | In distribution |
| AX083020001 | Height 37.5 in | In distribution |
| AX082020003 | Width 26 in | In distribution |
| 15090-02 | In distribution | |
| AX014111 | Width 24 in | In distribution |
| AX081010001 | Width 26 in | In distribution |
| 15966-93 | In distribution | |
| AX083010001 | Height 37.5 in | In distribution |
| 15966-22 | Width 27 in | In distribution |
| 15091-04 | In distribution | |
| 15966-92 | In distribution | |
| AX081020001 | Length 42 in | In distribution |
| 15091-13 | In distribution | |
| 15090-03 | In distribution | |
| AX06757 | Length 36 in | In distribution |
| AX082020001 | Length 54 in | In distribution |
| AX083020003 | Height 37.5 in | In distribution |
| AX000B7 | Width 24 in | In distribution |
| 15091-02 | In distribution | |
| AX081020003 | Width 26 in | In distribution |
| AX086020003 | Height 26 in | In distribution |
| 15966-03 | In distribution | |
| 15966-11 | Width 27 in | In distribution |
| 15090-14 | In distribution | |
| 15091-14 | In distribution | |
| 15966-04 | In distribution | |
| AX085010001 | Height 26 in | In distribution |
| AX000B6 | Height 36 in | In distribution |
| AX084020003 | Length 39 in | In distribution |
| 15090-12 | In distribution | |
| FV022005 | Height 20 in | In distribution |
| AX085020001 | Width 26 in | In distribution |
| 15090-04 | In distribution | |
| AX085020003 | Height 26 in | In distribution |
| 15966-44 | Width 51 in | In distribution |
| AX084020001 | Length 39 in | In distribution |
| AX082010001 | Width 26 in | In distribution |
| 15966-91 | In distribution | |
| 15091-03 | In distribution | |
| AX01311 | Width 24 in | In distribution |
| AX014112 | Length 48 in | In distribution |
| 15966-94 | In distribution | |
| AX084010001 | Length 39 in | In distribution |
| 15966-33 | Width 39 in | In distribution |
| 15090-13 | In distribution | |
| AX086010001 | Length 61 in | In distribution |
| 15966-01 | In distribution | |
| 15966-02 | In distribution | |
| 15990-04 | Withdrawn | |
| 15990-02 | Withdrawn | |
| 15990-05 | Withdrawn | |
| 15990-03 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
| Bravo 21V Autoclave | Scican Ltd. | 17 |
Showing 12 of 119. All products under Sterilizer, Steam
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2019-10-22 | Class II | Process control | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward | 237 units | 2020-06-09 |
| Steris Corporation | 510(k) number | 2018-12-26 | Class II | Device Design | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side. | 129 | 2020-06-16 |
| Steris Corporation | 510(k) number | 2015-09-03 | Class III | Software design | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door. | 32 units | 2016-01-22 |
| Steris Corporation | 510(k) number | 2015-02-19 | Class II | Software design (manufacturing process) | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a pr | 701 units | 2016-01-20 |
| Steris Corporation | 510(k) number | 2013-10-18 | Class II | Device Design | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. | 936 units | 2014-05-13 |
| Steris Corporation | 510(k) number | 2013-02-12 | Class II | Software design | The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used | 395 Units | 2013-12-05 |
| Steris Corporation | 510(k) number | 2012-03-23 | Not classified | Device Design | Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with | 523 | 2013-06-11 |
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.