ACOM.M angiographic x ray system. Model number 4371741
FDA device recall Z-1477-04 · posted 2004-09-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- possible problem reviewing images on the ACOM.M
- Action taken
- Strategy: The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX026/04/S. The letter informs the customers of the potential problem and provides preventive measures to avoid this occurrence.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 230 units
- Distribution
- Shipping: The product is shipped to 100 medical facilities in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, an
- Date initiated
- 2004-06-16
- Date posted
- 2004-09-18
- Date terminated
- 2005-04-11
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOP ACOM STATION (K945293) | Siemens Medical Solutions USA, Inc. | 1995-01-05 |