Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is de
FDA device recall Z-2601-2016 · posted 2016-08-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
- Action taken
- Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KHP
- Quantity affected
- 76
- Distribution
- Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
- Date initiated
- 2016-07-05
- Date posted
- 2016-08-19
- Date terminated
- 2017-08-02
- Location
- Norwood, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |