Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
FDA device recall Z-0717-2011 · posted 2010-12-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- patient leg can be pinched
- Action taken
- SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners. If you have any questions, please contact +1-888-826-9702.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 24 units
- Distribution
- Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
- Date initiated
- 2010-10-25
- Date posted
- 2010-12-17
- Date terminated
- 2012-09-29
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |