ACOM.M angiographic x ray system. Model numbers 5215707

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: June 16, 2004
Posted: September 18, 2004
Terminated: April 11, 2005
Recall Number: Z-1478-04
Quantity: 9 units
Firm Location: Malvern, PA

Reason for Recall

possible problem reviewing images on the ACOM.M

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.

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 WY

Lot / Code Info

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

Root Cause

Other

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.