The Recall Desk
HighFDA (Devices)·Z-1154-2020·Announced 2020-02-19

Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a failure could lead to hypercarbia and hypoxemia, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Respironics California, LLC is recalling 800 units of the Respironics RP-Touch Screen for V60/V680 Ventilators. These units were serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C. The affected touchscreens have serial numbers ranging from 41088-1808-0001 to 42805-1828-0138.

The recall is issued because the touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen. Consequently, a clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient, but a delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

The affected products were distributed in the United States and in numerous foreign countries, including Australia, Canada, China, France, Germany, India, Italy, Japan, Mexico, and the United Kingdom. Clinicians and facilities using these ventilators should check their equipment against the listed serial numbers and contact Respironics for further instructions.

The recalled product

Product
Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
Manufacturer
Respironics California, LLC
Category
Medical Device — Ventilator
Hazard
Affected units
800

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)

  • Touchscreen Serial Number: 41088-1808-0001 to 0179
  • 41213-1809-0001 to 0200
  • 41305-1811-0001 to 0295
  • 41379-1812-0001 to 0250
  • 41379-1812-0251 to 0328
  • 41540-1813-0001 to 0195
  • 41633-1814-0001 to 0275
  • 41633-1814-0276 to 0285
  • 41724-1815-0001 to 0140
  • 41724-1815-0141 to 0183
  • 41838-1816-0001 to 0107
  • 41838-1816-0108 to 0165
  • 41930-1817-0001 to 0092
  • 42059-1818-0001 to 0150
  • 42059-1818-0151 to 0183
  • 42161-1819-0001 to 0117
  • 42161-1819-0118 to 0137
  • 42232-1820-0001 to 0130
  • 42232-1820-0131 to 0146
  • 42334-1822-0001 to 0134

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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