Reported Jun 26, 2013 · Terminated
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613…
Respironics California Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Respironics California Inc · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517
Is this the product you have?
Respironics V60 VentilatorModel #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/N1054358
- Philips 12 Digit P/N4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals
- who require mechanical ventilationpatients 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
- Lot codes and dates
- V60 Unit Serial Numbers
2,962 of 2,962 codes
201001587201001594100066488100017106100017114100017223100017224100017230100017234100006282100078254100078560100078563100080057100013022100004544100013661100013664100013472100013658100042656100049569100005498100014349100014422100014430100014432100014436100014438100014439100014640100014643100014644100014935100014936100014938100014939100015003100082002100082006100082083100082084100045123100045295100030471100030479100030484100030602100034394100034398100034584100034587100041191100014350100025026100025032100025927100025929100025930100025943
- V60 Unit Serial Numbers
- Amount recalled
- 19,200 units total (12,060 units in US)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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