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Terminated

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

FDA Recall Z-0268-2018 · Posted 2017-12-20

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMHX
Date Initiated2017-09-20
Date Terminated2020-04-17
Product Quantity1079

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.

Firm Action

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

Root Cause

Error in labeling

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112652SURESIGNS VS2+ -SURESIGNS VSIPhilips Medical Systems · 2011-10-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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