Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10
FDA device recall Z-0016-2014 · posted 2013-11-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
- Action taken
- Siemens initiated this correction on May 6, 2013 by sending Update InstructionXP005/13/S. Firm subsequently issued a letter on June 3, 2013 to all accounts. 1. Siemens Field Modification of the Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, which improves the signal transmission for the automatic exposure control, is available as of May 2013, and systems will be updated within one year. 2. The revised software fix for models Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, will be provided to all identified customers at no charge. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Siemens Medical Solutions USA, Inc., will notify the FDA district office in Philadelphia, Pennsylvania, with reports of progress regarding this field correction.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 23
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-05-06
- Date posted
- 2013-11-01
- Date terminated
- 2014-11-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROSKOP OMNIA (K101491) | Siemens Medical Solutions USA, Inc. | 2010-06-30 |
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |