PRIMUS HI #04504200 with Digital LINAC Systems Control recall
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Why was PRIMUS HI #04504200 with Digital LINAC Systems Control recalled?
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)