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Class 2 Device Recall ACOM.M angiographic x ray system |
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| 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/
Manufacturer |
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
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| For Additional Information Contact |
Roland Richter
610-448-1777
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Manufacturer Reason
for Recall |
possible problem reviewing images on the ACOM.M
|
FDA Determined
Cause 2 |
Other |
| 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. |
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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.
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