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

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

Other recalls by Philips Electronics North America Corporation

  • Z-0614-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6. (November 15, 2018)
  • Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
  • Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3220-2018 Class II — NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
  • Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
  • Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3215-2018 Class II — INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular i (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)