Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit recallZ-2601-2016 · Siemens Healthcare Diagnostics Inc · initiated Jul 5, 2016
Class III Terminated All recalls posted in August 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2601-2016
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Jul 5, 2016
- Posted by the FDA
- Aug 19, 2016
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 76
- Product code
- KHP
- FDA submissions
- K113216
- Distribution
- Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Product description
Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Code information (models, lots, serial numbers)
Software Version 2.2A
Other devices under the same FDA submission
1 device cleared under K113216 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPIDPoint® 500 System 10492730Siemens Healthcare Diagnostics Inc. · ACID, LACTIC, ENZYMATIC METHOD1 recall1 death32 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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