PSW 1203.U/1 recall: Software Issue
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device…
Why was PSW 1203.U/1 recalled?
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
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?
Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
- Product
- PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device…
- Recalling firm
- BIOTRONIK, Inc.
- Quantity
- 768 units (software)
- Distribution
- Nationwide Distribution.
- Recall date
- August 19, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)