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Terminated

GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.

FDA Recall Z-1227-2009 · Posted 2009-06-01

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMHX
Date Initiated2009-02-24
Date Terminated2012-05-29
Product Quantity291

Reason for Recall

Intermittent or continuous loss of patient monitoring.

Firm Action

Consignees were sent on 2/20/09 a GE Healthcare "Urgent Medical Device Correction" letter dated 2/12/09. The letter was addressed to Risk Manger/Chief of Nursing/Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032369MODIFICATION TO: APEXPRO TELEMETRY SYSTEMGe Medical Systems Information Technologies · 2003-08-15

Official Source

View FDA Recall →

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

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