Z-1478-04

ACOM.M angiographic x ray system. Model numbers 5215707

Name: Z-1478-04 ACOM.M angiographic x ray system. Model numbers 5215707
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-06-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-06-16 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of ACOM.M angiographic x ray system. Model numbers 5215707 on 2004-06-16. The reason FDA records is "possible problem reviewing images on the ACOM.M". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1478-04
Status: Terminated
Initiated: 2004-06-16
Posted: 2004-09-18
Terminated: 2005-04-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACOM.M angiographic x ray system. Model numbers 5215707
Reason for recall: possible problem reviewing images on the ACOM.M
FDA root cause: 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.
Product codes and lots: Serial numbers 1087, 1088, 1089, 1093, 1094, 1493, 1174, 1176, and 1212.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)