Retiro De Equipo (Recall) de Philips V60 Ventilators

Recall

77084

Class 1

Z-2061-2017

2017-04-24

Completed

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154944

Over time, low-frequency vibrations can cause the pins within the female connectors on the motor controller to data acquisition board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.

The firm, Philips, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2017 to its customers. The Customers letter inform them that Respironics California is recalling the Philips V60 Noninvasive Ventilators manufactured before 15 September 2015; that the recall is for all V60s with date of manufacture before 15 September 2015 and not for V60 Ventilators manufactured on or after 15 September 2015; of the recall reason, risk to health, how to identify devices subject to recall, and actions to be taken the customers. The customers were also instructed to complete and return the RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: recall.response@philips.com or fax to: 1-877-499-7223 or mail to: Philips Healthtech, Mailstop# 4202, 3000 Minuteman Road, Andover, MA 01810-1032. On 5/9/17, Respironics has revised customer notification letter and began sending it out to their customers. The update includes the following actions to be taken: "appropriately trained personnel may continue using the V60" and "ensure an alternative form of ventilation device is available at all times, including intra-hospital transport (e.g. manual ventilation bag)." Philips will contact each consignee to schedule an appointment for this recall. Philip Engineers will remediate any affected V60 ventilators at the site. If you have any questions, please contact the Head of Q & R at 760-918-1067 or donald.sherratt@philips.com.