Transducer El18-4
Catalogue number 989605456291, listed by Philips Ultrasound LLC, United States, under Transducer, Ultrasonic, Diagnostic. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
39recalls on this code
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic
Record
| Listed by | Philips Ultrasound LLC, United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-05-02 |
| Record revised | 2024-06-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 989605456291 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 302 |
| Biopsy Starter Kit | Civco Medical Instruments Co., Inc. | 172 |
| Sheathes | Sheathing Technologies, Inc. | 170 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 156 |
| Sheathes3D | Sheathing Technologies, Inc. | 78 |
| Ultrasound Probe Cover Biopsy Needle Guide | Advance Medical Designs, Inc. | 78 |
| ultrasonic transducer | Edan Instruments, Inc. | 70 |
| Unbranded | Advance Medical Designs, Inc. | 68 |
| Reusable Biopsy Bracket | Protek Medical Products, Inc. | 60 |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | Advance Medical Designs, Inc. | 58 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 56 |
| Transducer Cover | Civco Medical Instruments Co., Inc. | 54 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091804 | 2009-07-17 |
| K081802 | 2008-07-11 |
| K870748 | 1987-04-10 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Ultrasound LLC | UDI-DI | 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| Philips Ultrasound LLC | UDI-DI | 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units |
Recalls
25 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 11 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 2 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 17 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 5 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 1 unit | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 1 unit | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 40 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 41 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 17 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 75 units | |
| 2025-09-05 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 2 units | |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units | |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2025-05-28 | Class II | Process control | Ultrasound transducer devices were refurbished beyond their useful life. | 5,230 units | |
| 2023-06-30 | Class II | Process control | Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safe | 449 | |
| 2019-08-30 | Class II | Process control | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the | 2024-11-27 | |
| 2019-08-30 | Class II | Process control | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the | 2024-11-27 | |
| 2019-08-30 | Class II | Process control | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the | 2024-11-27 | |
| 2019-08-30 | Class II | Process control | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the | 2024-11-27 |
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.