FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc. Oncology Systems: Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
- Recall number
- Z-2181-2011
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Product
- Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
- Status
- Terminated
- Initiated
- 2011-04-05
- Posted
- 2011-05-10
- Terminated
- 2012-06-19
- Reason
- Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
- Root cause
- Nonconforming Material/Component
- Action
- Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.
- Quantity
- 20
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047. Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.
- 510(k) numbers
- ["K092871"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- 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