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Terminated

Propaq LT vital signs monitor, Model 802LTON

FDA Recall Z-0215-2007 · Posted 2006-11-28

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMWI
Date Initiated2006-10-22
Date Terminated2011-08-02
Product Quantitytotal of both models 1031

Reason for Recall

Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.

Firm Action

A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals/medical centers and dealers worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033378VITAL SIGNS MONITOR, PROPAQ LTWelch Allyn Protocol, Inc. · 2004-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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