ACOM.M angiographic x ray system. Model numbers 5215707
FDA device recall Z-1478-04 · 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
- 9 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
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