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Terminated

Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709

FDA Recall Z-1687-2017 · Posted None

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeMNT
Date Initiated2017-02-01
Date Terminated2018-06-26
Product Quantity2512 units

Reason for Recall

The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.

Firm Action

Philips sent an Urgent- Medical Device Letter dated February 1, 2017, to all affected customers. It will be sent the week of February 6, 2017, to inform customers that Respironics is voluntarily recalling all Philips V60 Non Invasive Ventilators (NIV) that have Version 2.20 Software installed. Customers are informed that the V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease. An audible high-priority alarm will sound continuously for at least 2 minutes when the V60 shuts down for any Vent Inop condition and is operating on battery power. If the V60 is connected to AC power (mains supply), the alarm will continue to sound until an operator intervenes. If the V60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator. Error Code 100E only exists in V60 Version 2.20 software. Therefore, V60s running Version 2.10 software are not subject to this particular Vent Inop condition. E-mail back the complete form attached to the rear of this recall notification to recall. response @ Philips. com or Fax to 1-877 499-7223. For further questions please call (760) 918-7300.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Distribution and to the countries of : Argentina, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, Norway, Qatar, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc. · 2011-04-05

Official Source

View FDA Recall →

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

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