Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628

FDA device recall Z-1537-2013 · posted 2013-06-17 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.

Action taken

The firm, Philips Healthcare, sent a "MEDICAL DEVICE CORRECTION" letter dated June 3, 2013 to all customers who received the V60 Ventilators. The letter describes the product, problem identified and the actions to be taken. The customers were informed that the V60 ventilator may continue to be used in accordance with its directions for use, pending the completion of the update. In addition, the customers were instructed to refer to their manual for additional information on warnings. A Philips Field Service Engineer, Approved Sevice Provider or Distributor will be contacting the customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013. If you need any further information or support concerning this issue, contact your local Philips Respironics representative at (800) 722-9377.

Root cause

Software design

Status

Terminated

Product code

MNT

Quantity affected

19,200 units total (12,060 units in US)

Distribution

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecua

Date initiated

2013-06-04

Date posted

2013-06-17

Date terminated

2014-04-24

Location

Carlsbad, CA

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