Siemens RAPIDPoint 500 Software Upgrade Kit Recalled for Uncleared Mode
Siemens is recalling 76 RAPIDPoint 500 software upgrade kits because some include a dialysate mode not cleared for shipment in the United States.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue involves an uncleared software mode rather than a direct safety hazard.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 76 units of the RAPIDPoint 500 v2.2.2A Software Upgrade Kit (SMN 11066719, Software Version 2.2A). The recall was initiated because some of the upgrade kits include a dialysate mode that is not cleared or approved for shipment in the United States.
The RAPIDPoint 500 system is designed for professional use in point-of-care or laboratory environments to test blood gases, electrolytes, metabolites, and hemoglobin derivatives. The affected software upgrade kits were distributed nationwide to facilities in Alabama, California, Massachusetts, New Jersey, Ohio, Texas, Washington, and Pennsylvania.
Healthcare facilities should stop using the affected software upgrade kits and contact Siemens Healthcare Diagnostics Inc for further instructions on the recall.
The recalled product
- 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 in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version 2.2A
Distribution
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