FDA Medical Device Recalls (openFDA)
Ziehm Imaging Inc: Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
- Recall number
- Z-2641-2016
- Recalling firm
- Ziehm Imaging Inc
- Product
- Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
- Status
- Terminated
- Initiated
- 2016-04-15
- Posted
- not on file
- Terminated
- 2019-07-18
- Reason
- Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
- Root cause
- Device Design
- Action
- Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.
- Quantity
- 2 devices
- Distribution
- US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
- Lot, serial or model codes
- Serial #'s 20719 and 20721.
- 510(k) numbers
- ["K083545"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2027299
- Firm city
- Orlando
- Firm state
- FL
- 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