The Recall Desk
SevereFDA (Devices)·Z-1622-2020·Announced 2020-04-08

Philips V60 Ventilators Recalled for Power Management Board Failure

Respironics is recalling 23,581 Philips V60 Ventilators because a solder connection failure on the power board may cause the blower to lose power or shut down unexpectedly, potentially leading to hypercarbia or hypoxemia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that may lead to hypercarbia or hypoxemia, which are significant physiological injuries, meeting the criteria for a Severe rating.

Plain-English summary

Respironics California, LLC is recalling 23,581 units of Philips V60 Ventilators equipped with a Power Management PCBA part number 1055906. The recall is due to a solder connection failure on the Power Management printed circuit board assembly. This defect may cause the blower to lose power, spool down, and trigger a High Priority Check Vent alarm, or it may cause an intermittent connection that disrupts operation and triggers an unexpected shutdown without an alarm.

The affected ventilators were distributed across all 50 U.S. states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as numerous countries outside the United States. The specific serial numbers affected are 100002908 to 100027093, 100027096 to 100085389, 100085399 to 100109746, 100109868 to 201003390, and 201003392 to 201010952.

Failures of the power management board may lead to hypercarbia or hypoxemia. Users should check their device serial numbers against the affected ranges and contact Respironics for further instructions on corrective actions.

The recalled product

Product
Philips V60 Ventilators with Power Management PCBA part number 1055906
Affected units
23,581

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Serial Numbers: 100002908 to 100027093
  • 100027096 to 100085389
  • 100085399 to 100109746
  • 100109868 to 201003390
  • 201003392 to 201010952

Distribution