Company:Respironics, Inc
Date of Enforcement Report6/20/13
Date Recall Initiated: 6/2/2013
Class l:
PRODUCT
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. Z-1537-2013
REASON
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. This recalled product may cause serious adverse health consequences, including death.
RECALLING FIRM/MANUFACTURER
Respironics, Inc.,Carlsbad, California on 6/4/13. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
19,200 units total (12,060 units in US)
DISTRIBUTION
Nationwide and Internationally
FDA Comments:
On June 3, 2013, Philips Healthcare sent a “MEDICAL DEVICE CORRECTION” letter to all customers who received the V60 Ventilators. The letter described the product, the problem, and the actions to be taken.
Customers were informed that the V60 ventilator may continue to be used according to its directions for use, pending the completion of the software update. In addition, customers were instructed to refer to their manual for additional information on warnings.
A Philips Field Service Engineer, Approved Service Provider, or Distributor will be contacting 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.
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