Home / Recalls / Philips Electronics North America Corporation / Z-0268-2018

Z-0268-2018 Class III Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

FDA device recall Z-0268-2018 was initiated by Philips Electronics North America Corporation on September 20, 2017 and is designated Class III. 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. The recall status is terminated (terminated April 17, 2020). Affected quantity: 1079.

Recall Details

Product Type: Devices
Report Date: December 27, 2017
Initiation Date: September 20, 2017
Termination Date: April 17, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1079

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.

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.

Code Information

SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279

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