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Terminated

BirthNet OB Data Management System 91861

FDA Recall Z-0115-06 · Posted 2005-11-01

Recalling FirmSpacelabs Medical Incorporated
Recall StatusTerminated
Product CodeHGM
Date Initiated2005-10-13
Date Terminated2011-01-17
Product Quantity44 devices

Reason for Recall

Potential for incorrect weight to be displayed.

Firm Action

On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.

Root Cause

Other

Distribution Pattern

Distribution was to 44 medical facilities/hospitals nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965008BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEMSpacelabs Medical, Inc. · 1997-12-16

Official Source

View FDA Recall →

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

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