FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis Zee. Angiographic X-ray System.
- Recall number
- Z-0194-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis Zee. Angiographic X-ray System.
- Status
- Terminated
- Initiated
- 2008-08-22
- Posted
- 2008-11-04
- Terminated
- 2009-09-23
- Reason
- Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.
- Root cause
- Labeling design
- Action
- The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.
- Quantity
- 108 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Serial numbers: 135000, 135102, 135109, 135111, 135112, 135114, 135117, 135120, 135122, 135124, 135125, 135128, 135129, 135133, 135137, 135143, 135144, 135145, 135148, 135151, 135152, 135157, 135169, 140100, 140101, 140102, 146103, 146104, 146107, 146111, 146113, 146116, 146118, 146119, 146121, 146122, 146123, 146124, 146130, 146137, 146138, 146139, 146140, 146144, 146147, 146149, 146150, 146154, 146155, 146152, 146156, 146158, 146159, 146161, 146164, 146166, 146167, 146168, 146170, 146171, 146173, 153101, 153102, 153106, 153107, 153109, 153110, 153111, 153112, 153113, 153115, 153117, 153119, 153120, 153122, 153124, 153125, 153128, 153129, 153130, 153131, 153132, 153134, 153135, 153139, 153141, 153145, 153147, 153148, 153150, 153153, 153154, 153155, 153156, 153157, 153159, 153160, 153161, 153164, 153166, 153167, 153169, 153171, 153172, and 153173.
- 510(k) numbers
- ["K073290"]
- 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