Philips SureSigns Vital Signs Monitors Recalled for Labeling Error
Philips is recalling SureSigns VSi and VS2+ vital signs monitors because some units have a placeholder date of manufacture instead of the specific date.
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. The issue is a documentation and labeling error rather than a functional safety defect.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,079 units of SureSigns VSi and SureSigns VS2+ vital signs monitors. These devices are used in healthcare environments and for transport within a facility.
The recall is due to a labeling error where some products have the Date of Manufacture on the serial number label listed as "%DoM" instead of the specific date in the YYYY-MM format. The affected products were distributed worldwide to numerous countries, including the United States, United Kingdom, Germany, and Australia.
Healthcare facilities should check their inventory for these specific models and serial number codes. If a device is found with the incorrect date format, it should be removed from service and reported to Philips.
The recalled product
- Product
- Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 1,079
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 (4)
- SureSigns VSi : 863275
- 863276
- 863277 SureSigns VS2+ : 863278
- 863279
Distribution
Distribution scope not specified by the agency.
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