Reported May 6, 2020 · Terminated
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing…
Welch Allyn, Inc/mortara
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: WELCH ALLYN, INC/MORTARA · 7865 N 86th St · Milwaukee, WI · 53224-3431
Is this the product you have?
- Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
- Lot codes and dates
- Same as X12+ Model Number X12PLUS-XXX-XXXXX
- Amount recalled
- 78,521 units total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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