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Terminated

GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

FDA Recall Z-1526-2010 · Posted 2010-05-11

Recalling FirmGe Healthcare, Llc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2010-03-12
Date Terminated2012-01-30
Product Quantity15 (OUS)

Reason for Recall

Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

Firm Action

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Root Cause

Process design

Distribution Pattern

Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090233GE DATEX-OHMEDA AISYSDatex-Ohmeda, Inc. · 2009-03-05

Official Source

View FDA Recall →

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

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