Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ra
FDA device recall Z-1732-2010 · posted 2010-05-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
- Action taken
- Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 83 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-04-12
- Date posted
- 2010-05-28
- Date terminated
- 2013-04-11
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |