Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
FDA device recall Z-1848-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
- Action taken
- Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 4
- Distribution
- US Distribution including the states of CA, IN, NJ and OK.
- Date initiated
- 2013-05-07
- Date posted
- 2013-08-01
- Date terminated
- 2013-12-24
- 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 |