AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can resul
FDA device recall Z-0101-2009 · posted 2008-10-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.
- Action taken
- The recalling firm was made aware of a potential problem with the device from the manufacturer in Germany. The recalling firm sent a copy of the Customer Safety Advisory Notice, dated June 18, 2008, received from Germany to their customers. The recalling firm has representatives visiting each location to modify the units.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 211 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-08-12
- Date posted
- 2008-10-10
- Date terminated
- 2009-10-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM SIRESKOP SD (K051602) | Siemens Medical Systems, Inc. | 2005-07-07 |