Recalls / —
—#160243
Product
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
- FDA product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K112652
- Affected lot / code info
- SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279
Why it was 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.
Root cause (FDA determination)
Error in labeling
Action the firm took
Philips sent each known affected customer a Field Safety Notice, dated September, 2017. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a corrected label free of charge
Recalling firm
- Firm
- Philips Electronics North America Corporation
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2017-09-20
- Posted by FDA
- 2017-12-20
- Terminated
- 2020-04-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.