FDA Medical Device Recalls (openFDA)
Orthoscan, Inc.: Ziehm Vision system, x-ray, tomography, computed.
- Recall number
- Z-0575-2025
- Recalling firm
- Orthoscan, Inc.
- Product
- Ziehm Vision system, x-ray, tomography, computed.
- Status
- Open, Classified
- Initiated
- 2024-08-08
- Posted
- 2024-12-02
- Terminated
- not on file
- Reason
- Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Ziehm Imaging, Inc. intends to notify the affected customers directly in the following manner: 1) Letter with return receipt requested, envelope, return, and reply to questionnaire, or E-mail contact. 2) Direct phone calls. Once contact is made and confirmed Ziehm Imaging Inc, shall provide replacement hand switch and instructions to the end user. Wired Hand switch 88036 Vl.02 will be requested to be returned by the customer/end user to Ziehm Imaging Inc. and will be subjected to be scrapped.
- Quantity
- 3
- Distribution
- U.S. (including Puerto Rico).
- Lot, serial or model codes
- UDI: EZIEZIEHMVISIONFD1 Serial Numbers: 9246, 90155, 90416.
- 510(k) numbers
- ["K073346"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3005254598
- Firm city
- Scottsdale
- Firm state
- AZ
- 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