FDA Medical Device Recalls (openFDA)
Impac Medical Systems Inc: Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.
- Recall number
- Z-0052-2012
- Recalling firm
- Impac Medical Systems Inc
- Product
- Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.
- Status
- Terminated
- Initiated
- 2011-09-09
- Posted
- 2011-10-17
- Terminated
- 2012-03-06
- Reason
- Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.
- Root cause
- Nonconforming Material/Component
- Action
- " Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email support@impac.com or call. The letter provided consignees with a complete list of contact information..
- Quantity
- 11 devices
- Distribution
- Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.
- Lot, serial or model codes
- All sites with the configuration of the 4D IEC 1217 source file used for the Varian TrueBEam treatment machine.
- 510(k) numbers
- ["K981313"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000123805
- Firm city
- Sunnyvale
- 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
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