The Recall Desk
HighFDA (Devices)·Z-0633-2014·Announced 2014-01-15

Welch Allyn Propaq LT Series Monitors Recalled for Potential Operational Interruption

Welch Allyn is updating software on Propaq LT Series monitors because rare hardware or software faults could interrupt device operations.

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 fault could interrupt operations, posing a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Welch Allyn Protocol, Inc. is recalling the Propaq LT Series vital signs monitors, specifically models 802LTAN, 802LT0N, and 802LTRN. These devices are used in hospitals, emergency departments, and other healthcare settings to monitor ECG, noninvasive blood pressure, respiration, and SpO2.

The recall is being conducted to update the software on these monitors. The update addresses fault conditions related to hardware or software failure, or electrical noise caused by proximal defibrillation activity. In rare instances, these conditions could potentially interrupt device operations.

A total of 6,003 units are affected, with 1,715 units distributed in the United States and 4,288 units distributed internationally. The devices were distributed to various healthcare facilities worldwide. Healthcare facilities should check their device serial numbers against the list provided by the FDA and contact Welch Allyn for the software update.

The recalled product

Product
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-surgic

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)

  • SERIAL NUMBERS OF DEVICES DISTRIBUTED IN THE US: KA008788
  • KA009581
  • KA009685
  • KA009776
  • KA009917
  • KA010079
  • KA010193
  • KA010996
  • KA011141
  • KA011192
  • KA011227
  • KA011228
  • KA011231
  • KA011249
  • KA011303
  • KA011307
  • KA011311
  • KA011314
  • KA011327
  • KA011355

Distribution

Distributed nationwide across the United States.