Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 27, 2017
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Electronics North America Corporation recalled Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environmen… - a low-severity action.
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environmen… was recalled by Philips Electronics North America Corporation in December 27, 2017. Reason: Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead …. Check the official notice for the remedy. Verify recall #Z-0268-2018 with the FDA Devices before acting.
The recall
Philips Electronics North America Corporation issued this low-severity FDA Devices recall-Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead ….
- Low
- severity level
- 1K units
- affected scope
- Class III
- classification
- December 27, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0268-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0268-2018) was formally reported on December 27, 2017, with the manufacturer initiating the action on September 20, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Philips Electronics North America Corporation is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 1079.
The documented reason for this recall is: Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM. Distribution data in the federal record shows the product reached: Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlan…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1079
Related Recalls
6
3 from same agency
Product description
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Reason for recall
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0268-2018 |
| Date reported | December 27, 2017 |
| Date initiated | September 20, 2017 |
| Recalling firm | Philips Electronics North America Corporation |
| Firm location | Andover, MA |
| Affected scope | 1079 |
| Distribution | Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0268-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.. Recalled by Philips Electronics North America Corporation. Units affected: 1079.
Why was this product recalled? ▼
Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2017. Severity: Low. Recall number: Z-0268-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, UAE, Vietnam, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0268-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 27, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.