FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
- Recall number
- Z-0997-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
- Status
- Terminated
- Initiated
- 2013-03-08
- Posted
- 2013-03-26
- Terminated
- 2014-11-06
- Reason
- The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
- Root cause
- Software design
- Action
- Siemens sent a Customer Safety Advisory Notice on March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information on to all those who need to be aware of it and to instruct their personnel accordingly. Customers were asked to forward the safety information to other organizations that couald be affected by this action. For questions regarding this recall call 610-219-6300.
- Quantity
- 81
- Distribution
- Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
- Lot, serial or model codes
- Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.
- 510(k) numbers
- ["K073290","K090745"]
- PMA numbers
- not on file
- Product code
- IZI
- 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