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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Percussionaire Corporation: Monitron II Waveform Analyzers Recalled for Screen Freeze Malfunction

Agency Publication Date: November 7, 2023
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Summary

Percussionaire Corporation has recalled 212 Monitron II Waveform Analyzers because the visual display screens can freeze while being used with ventilators. This issue, which primarily occurred in 2020 and 2021, means the device may stop showing critical real-time breathing data to healthcare providers. Affected units were subsequently serviced to install new microprocessor chips and firmware to prevent this failure.

Risk

If the screen freezes, medical staff cannot accurately monitor the patient's breathing waveforms or ventilator performance. This could lead to a delay in recognizing a change in the patient's condition or a malfunction in the ventilator, potentially resulting in patient harm.

What You Should Do

  1. Check the back or side of your Monitron II Waveform Analyzer to identify the Reference Number (REF) S00015-1 and the Universal Device Identifier (UDI-DI) 00849436000068.
  2. Verify if your device's serial number is among the 212 affected units, which include WF21150, WF21159, WF21163, WF21164, WF21167, WF21171, WF21371, WF21372, WF21377, WF21378, and others in the WF21150 through WF21391 range.
  3. Ensure your device has been serviced to include the required PAL microprocessor chips and firmware updates as part of the manufacturer's corrective action.
  4. Contact your healthcare provider or Percussionaire Corporation at their Sandpoint, Idaho facility (130 Mcghee Rd Ste 109) to confirm your device has received the necessary hardware and software updates.
  5. For additional information or to report concerns, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

You have 2 options:

๐Ÿ”งOption 1: Free Repair

Installation of microprocessor chips and firmware

How to: Devices were serviced to install PAL microprocessor chips and firmware to resolve the screen freeze issue.
๐Ÿ“‹Option 2: Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Monitron II Waveform Analyzer
Model / REF:
REF: S00015-1
UPC Codes:
00849436000068
Lot Numbers (212):
WF21150
WF21159
WF21163
WF21164
WF21167
WF21171
WF21371
WF21372
WF21377
WF21378
WF21158
WF21391
WF21165
WF21166
WF21168
WF21169
WF21170
WF21172
WF21173
WF21174
WF21175
WF21176
WF21177
WF21178
WF21179
WF21182
WF21183
WF21184
WF21185
WF21186
WF21187
WF21188
WF21189
WF21190
WF21192
WF21193
WF21194
WF21195
WF21196
WF21197
WF21198
WF21199
WF21200
WF21201
WF21202
WF21203
WF21204
WF21205
WF21206
WF21207
Date Ranges: Recalled occurred in 2020 and 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93192
Status: Resolved
Manufacturer: Percussionaire Corporation
Sold By: Percussionaire Corporation
Manufactured In: United States
Units Affected: 212
Distributed To: California, North Dakota, Mississippi, Maryland

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.