FDA Medical Device Recalls (openFDA)
Varian Medical Systems: GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
- Recall number
- Z-0486-2007
- Recalling firm
- Varian Medical Systems
- Product
- GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
- Status
- Terminated
- Initiated
- 2006-09-11
- Posted
- 2007-01-11
- Terminated
- 2007-05-18
- Reason
- Medical device for patient treatment does not meet electrical safety standards.
- Root cause
- Other
- Action
- The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.
- Quantity
- 31 total units
- Distribution
- Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
- Lot, serial or model codes
- H630701 H630703 H630704 H630705 H630706 H630708 H630710 H630711 H630712 H630713 H630714 H630715 H630716 H630718 H630719 H630720 H630721 H630722 H630723 H630724 H630725 H630727 H630728 H630729 7H63030 H630732 H630733 H630735 H630736 H630737 H630739
- 510(k) numbers
- ["K891131","K912555"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 3000206172
- Firm city
- Charlottesville
- Firm state
- VA
- 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