Recall Z-0268-2018— Philips Electronics North America Corporation

Name: FDA recall Z-0268-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-20

Class III · Terminated

Class III FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-09-20, terminated 2020-04-17. It names one FDA 510(k) clearance: K112652. Product: Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.. Reason: 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..

Recalling firm: Philips Electronics North America Corporation
Classification: Class III
Status: Terminated
Initiated: 2017-09-20
Terminated: 2020-04-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112652 — SURESIGNS VS2+ -SURESIGNS VSIPhilips Medical Systems·cleared 2011-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.