Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Sti
FDA device recall Z-1600-2016 · posted 2016-05-03 · Terminated
Recall details
- Recalling firm
- Nuvectra
- Reason for recall
- If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.
- Action taken
- Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 17 OUS
- Distribution
- Germany
- Date initiated
- 2016-04-06
- Date posted
- 2016-05-03
- Date terminated
- 2017-09-29
- Location
- Blaine, MN
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