SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagno
FDA device recall Z-2222-2010 · posted 2010-08-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.
- Action taken
- Siemens Healthcare Sector sent an "Urgent Field Safety Notice" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 1296
- Distribution
- Nationwide distribution: all 50 US states and PR.
- Date initiated
- 2010-07-13
- Date posted
- 2010-08-13
- 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 |
| AXIOM SIRESKOP SD (K051602) | Siemens Medical Systems, Inc. | 2005-07-07 |