FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Recall number
- Z-1680-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Status
- Terminated
- Initiated
- 2020-02-18
- Posted
- not on file
- Terminated
- 2021-02-09
- Reason
- Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Root cause
- Use error
- Action
- A Customer Safety Advisory Notice was sent to all affected consignees on 2/18/2020 via Adobe Mega Sign or USPS certified mail. The notice describes the interlock scenarios, provides user instructions, and warns the user of potential risks. The interlock scenarios are as follows: MONITOR 2: Monitor 2 total dose coincidence. Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment. TREATMENT TIME: Preset treatment time coincidence with actual treatment time. Intent: This interlock is intended to prevent overdose if preset treatment time is exceeded. MONITOR SYNC (SW): Excessive accumulated dose deviation detected between the primary and the secondary dose monitoring systems. Intent: This interlock is intended to prevent patient mistreatment due to the inaccurate monitoring of delivered dose. When one or more of the above described interlocks occur, it may be assumed that there is an error in the dose monitor system.The Consumer Safety Advisory Notice states that the Operator's Manual Instructions Update document should be added to the product's manual and all users should be informed of the issues.
- Quantity
- 230,001
- Distribution
- Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming
- Lot, serial or model codes
- Serial Numbers 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832, 3667, 3924, 3949, 4036, 70-4185, 5153, 3361, 3979, 3657, 3679
- 510(k) numbers
- ["K993425"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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