Reported Jan 15, 2014 · Terminated
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG,…
Welch Allyn Protocol, Inc.
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 Protocol, Inc · 8500 Sw Creekside Pl · Beaverton, OR · 97008
Is this the product you have?
- The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
- Lot codes and dates
- SERIAL NUMBERS
- OF DEVICES DISTRIBUTED IN THE US
1,715 of 1,715 codes
KA008788KA009581KA009685KA009776KA009917KA010079KA010193KA010996KA011141KA011192KA011227KA011228KA011231KA011249KA011303KA011307KA011311KA011314KA011327KA011355KA011356KA011609KA011610KA011611KA011667KA011671KA011672KA011673KA011674KA011675KA011676KA011677KA011678KA011682KA011731KA011758KA020006KA020007KA020008KA020009KA020010KA020011KA020012KA020013KA020014KA020015KA020016KA020018KA020023KA020088KA020091KA020092KA020093KA020116KA020135KA020140KA020149KA020150KA020151KA020192
- OF DEVICES DISTRIBUTED OUTSIDE THE US
1,534 of 1,534 codes
KA002129KA002130KA008395KA008397KA008401KA008600KA008715KA008794KA009204KA009205KA009208KA009212KA009260KA009268KA009350KA009393KA009394KA009395KA009396KA009397KA009399KA009400KA009402KA009404KA009406KA009407KA009408KA009429KA009438KA009446KA009449KA009451KA009452KA009457KA009458KA009470KA009504KA009572KA009575KA009578KA009579KA009587KA009611KA009665KA009666KA009667KA009668KA009669KA009671KA009672KA009675KA009677KA009690KA009693KA009699KA009707KA009708KA009755KA009796KA009822
- Amount recalled
- 6003 units total (1715 units in the US and 4288 outside the US)
Where it was sold
- Nationwide
Why it was recalled
Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
This product could cause temporary or reversible health problems — stop using it.
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