Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit recall
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use…
Why was Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit recalled?
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
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?
Software Version 2.2A
- Product
- Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 76
- Distribution
- Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
- Recall date
- August 31, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)