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Terminated

ACOM.M angiographic x ray system. Model number 4371741

FDA Recall Z-1477-04 · Posted 2004-09-18

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Date Initiated2004-06-16
Date Terminated2005-04-11
Product Quantity230 units

Reason for Recall

possible problem reviewing images on the ACOM.M

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945293TOP ACOM STATIONSiemens Medical Solutions USA, Inc. · 1995-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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