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Terminated

Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00

FDA Recall Z-0538-04 · Posted 2004-02-13

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeDSI
Date Initiated2003-12-31
Date Terminated2005-01-06
Product Quantity233 devices

Reason for Recall

Potential failure to audibly alarm due to speaker hardware component failure.

Firm Action

The firm sent a letter dated December 31, 2003 instructing their customers to install an audio cable from the CPU to the Flat Panel Monitor to provide redundant speaker capability. The audio cable and installation instructions were included in the letter. The letter also included a Correction Response Form which customers should fill out upon completion of correction.

Root Cause

Other

Distribution Pattern

The firm distributes the product nationwide and internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022453MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEMWelch Allyn Protocol, Inc. · 2002-08-21

Official Source

View FDA Recall →

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

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