The Propaq LT Series monitors — Class II medical device recall Z-0633-2014
Terminated recall by Welch Allyn Protocol, Inc, reported 2014-01-15, distributed nationwide. Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with sof
| Recall number | Z-0633-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Welch Allyn Protocol, Inc, Beaverton, OR, United States |
| Recall initiated | 2013-11-21 |
| Classified | 2014-01-07 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2015-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CH, CL, CN, CR, CZ, DE, DK, EC, ES, FR, GB, GR, HK, IE, IT, JP, KR, KW, LT, MX, MY, NL, PL, PT, QA, RU, SA, SG, SV, TH, TR, TW, VN, ZA |
| Reason classes | software |
| Model numbers | 802LT0N, 802LTAN, 802LTRN |
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-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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.