The Recall Desk
SevereFDA (Devices)·Z-2074-2021·Announced 2021-07-28

Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

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: FDA Class I classification requires minimum score of 4. The device malfunction causes unintended reduction of oxygen flow below clinician-set levels, risking moderate to severe hypoxemia in ventilator-dependent patients.

Plain-English summary

Philips is recalling Respironics V60 Plus Ventilators with software versions 3.00 and 3.10. These devices are assist ventilators intended to augment breathing in patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in hospital and institutional settings. A total of 23,115 systems have been distributed worldwide.

The ventilators include a High Flow Therapy safety mechanism designed to limit the maximum pressure delivered to patients. However, when system pressure reaches the maximum threshold and triggers a "Cannot Reach Target Flow" alarm, the ventilator reduces both the pressure and the flow rate below what the clinician has set. If the underlying cause of the pressure increase is not resolved, the ventilator continues delivering the lower flow rate, which can result in patients experiencing oxygen desaturation characterized as moderate or severe hypoxemia.

Clinicians and healthcare providers should be aware of this potential malfunction and monitor patients using affected ventilators for signs of inadequate oxygen saturation.

The recalled product

Product
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation
Manufacturer
Respironics California, LLC
Category
Medical Device — Ventilator
Hazard

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 (20)

  • Model V60 Plus Ventilator: P/N 1138747 and 1137276
  • US System Serial Number/UDI Code: 100363973/
  • 100366525/
  • 100366542/
  • 100371876/ (01)00884838090996(21)100371876
  • 100373102/ (01)00884838090996(21)100373102
  • 100374459/ (01)00884838090996(21)100374459
  • 100376350/ (01)00884838090996(21)100376350
  • 100377311/ (01)00884838090996(21)100377311
  • 100377324/ (01)00884838090996(21)100377324
  • 100380441/ (01)00884838090996(21)100380441
  • 100382407/ (01)00884838090996(21)100382407
  • 100382452/ (01)00884838090996(21)100382452
  • 100382461/ (01)00884838090996(21)100382461
  • 100384413/ (01)00884838090996(21)100384413
  • 100384748/ (01)00884838090996(21)100384748
  • 100385425/ (01)00884838090996(21)100385425
  • 100385428/ (01)00884838090996(21)100385428
  • 100385429/ (01)00884838090996(21)100385429
  • 100385447/ (01)00884838090996(21)100385447

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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