FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc.: Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
- Recall number
- Z-0760-2013
- Recalling firm
- Varian Medical Systems, Inc.
- Product
- Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
- Status
- Terminated
- Initiated
- 2012-04-12
- Posted
- 2013-01-31
- Terminated
- 2014-04-10
- Reason
- A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
- Root cause
- Component design/selection
- Action
- Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory.
- Quantity
- 152 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K011657"]
- 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
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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