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U.S. Department of Health and Human Services

Class 2 Device Recall ACOM.M angiographic x ray system

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  Class 2 Device Recall ACOM.M angiographic x ray system see related information
Date Initiated by Firm June 16, 2004
Date Posted September 18, 2004
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-1478-04
Recall Event ID 29823
Product ACOM.M angiographic x ray system. Model numbers 5215707
Code Information Serial numbers 1087, 1088, 1089, 1093, 1094, 1493, 1174, 1176, and 1212.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
possible problem reviewing images on the ACOM.M
FDA Determined
Cause 2
Action 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.
Quantity in Commerce 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, and WY and 2 government accounts in CA and WI.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.