FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ACOM.M angiographic x ray system. Model number 4371741
- Recall number
- Z-1477-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ACOM.M angiographic x ray system. Model number 4371741
- Status
- Terminated
- Initiated
- 2004-06-16
- Posted
- 2004-09-18
- Terminated
- 2005-04-11
- Reason
- possible problem reviewing images on the ACOM.M
- 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
- 230 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.
- Lot, serial or model codes
- Serial numbers: 1024 through 1639
- 510(k) numbers
- ["K945293"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28