CLASS III Device recall · Reported 31 Aug 2016 · FDA Enforcement Report
Siemens RAPIDPoint¿ 500 v2.2.2A recalled
Siemens Healthcare Diagnostics is recalling Siemens RAPIDPoint¿ 500 v2.2.2A, distributed nationwide in the US. The recall was initiated on 5 Jul 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2601-2016
- FDA event ID
- 74564
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jul 2016
- FDA classified
- 19 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 5 Jul 2016 | Recall initiated by company | |
| 19 Aug 2016 | Classified by FDA | +45 days |
| 31 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Nationwide AlabamaCaliforniaMassachusettsNew JerseyOhioPennsylvaniaTexasWashington
Questions about this recall
Is Siemens RAPIDPoint¿ 500 v2.2.2A recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens RAPIDPoint¿ 500 v2.2.2A on 5 Jul 2016. The recall is Class III and its status is Terminated. Recall number Z-2601-2016.
Why was it recalled?
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Which lots are affected?
Software Version 2.2A
Where was it sold?
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Siemens Healthcare Diagnostics
All 694| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS III | Syva Emit Disopyramide Assay Enzyme Immunoassay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS III | Syva Emit tox Serum Tricyclic Antidepressant recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |