FDA Medical Device Recalls (openFDA)
Impac Medical Systems Inc: Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
- Recall number
- Z-0076-2011
- Recalling firm
- Impac Medical Systems Inc
- Product
- Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
- Status
- Terminated
- Initiated
- 2010-09-02
- Posted
- 2010-10-18
- Terminated
- 2011-06-24
- Reason
- Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
- Root cause
- Software design
- Action
- Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672
- Quantity
- 797 units
- Distribution
- Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK.
- Lot, serial or model codes
- All sequencers for all M/A and MOSAIQ builds..
- 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