The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical
FDA device recall Z-1849-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).
- Action taken
- All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 55
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-26
- Date terminated
- 2016-09-12
- Location
- Charlottesville, VA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER (K122236) | Varian Medical Systems, Inc. | 2012-11-16 |