Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha an
FDA device recall Z-2848-2020 · posted 2020-08-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
- Action taken
- Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- US: 282 units; OUS: 1363
- Distribution
- Nationwide
- Date initiated
- 2020-07-14
- Date posted
- 2020-08-22
- Date terminated
- 2021-07-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cios Spin (K181550) | Siemens Medical Solutions USA, Inc. | 2018-10-30 |
| Cios Alpha (K181560) | Siemens Medical Systems USA, Inc. | 2018-10-24 |
| CIOS ALPHA (K132094) | Siemens Medi Cal Solutions, Inc. | 2014-03-11 |