Recalls / —

—#34596

Product

ACOM.M angiographic x ray system. Model numbers 5215707

Affected lot / code info

Serial numbers 1087, 1088, 1089, 1093, 1094, 1493, 1174, 1176, and 1212.

Why it was recalled

possible problem reviewing images on the ACOM.M

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

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, and WY and 2 government accounts in CA and WI.

Timeline

Recall initiated

2004-06-16

Posted by FDA

2004-09-18

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.