Z-2851-2018Class II
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Philips Medical Systems DMC GmbH / initiated 2018-06-27 / Terminated / root cause: design
Philips Medical Systems Gmbh, DMC began a recall of DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 on . FDA classified it as Class II and gives the reason as "The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2851-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips Medical Systems DMC GmbH
- Product
- DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
- Product code
- MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Reason for recall
- The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
- Distribution
- US Nationwide; International to 66 countries
- Product codes and lots
- Serial Numbers: SN17000294 SN17000295 SN17000114 SN17000185 SN17000362 SN17000263 SN17000264 SN17000399 SN15000017 SN17000235 SN18000001 SN17000414 SN17000376 SN16000352 SN17000311 SN17000070 SN14000079 SN14000080 SN17000044 SN17000346 SN14000052 SN17000045 SN17000351 SN17000038 SN17000262 SN17000126 SN15000122 SN17000100 SN17000422 SN17000359 SN16000390 SN15000048 SN17000084 SN16000386 SN17000106 SN17000288 SN17000278 SN17000335 SN16000394 SN16000387 SN17000151 SN17000352 SN17000329 SN17000349 SN17000303 SN17000334 SN17000216 SN17000305 SN17000398 SN15000328 SN17000289 SN17000411 SN17000436 SN17000090 SN15000006 SN17000179 SN17000034 SN17000231 SN16000355 SN17000166 SN17000127 SN16000421 SN16000398 SN14000105 SN16000430 SN16000418 SN17000150 SN17000092 SN15000054 SN15000097 SN15000110 SN17000373 SN15000132 SN14000040 SN14000045 SN15000098 SN16000435 SN15000142 SN15000151 SN17000141 SN15000410 SN15000417 SN16000402
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2841-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2842-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2843-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2844-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2845-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2846-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2847-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2848-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2849-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2850-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2851-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2852-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2853-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2854-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2855-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2856-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2857-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2858-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2859-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2860-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2861-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2862-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2863-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2864-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2865-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2866-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2867-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2868-2018 | Class II | Terminated | Voluntary: Firm initiated |
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