Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical
FDA device recall Z-0076-2011 · posted 2010-10-18 · Terminated
Recall details
- Recalling firm
- Impac Medical Systems Inc
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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, Irela
- Date initiated
- 2010-09-02
- Date posted
- 2010-10-18
- Date terminated
- 2011-06-24
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |