The affected devices were distributed between Oct. 9 and Oct. 29, 2009. They include the following lot numbers:
- Aisys (model no. 1011-9000-000) — ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873
- Avance (model no. 1009-9002-000) — ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289
The Aisys and Avance systems are prescription devices used in healthcare settings under the supervision of a physician and are used to provide general inhalation anesthesia and ventilation support to a wide range of patients, according to the release.
Customers were notified by the FDA on March 12, 2010. Adverse events associated with the device may be reported to the FDA’s MedWatch program.
Read the FDA’s recall of GE’s Aisys and Avance Anesthesia systems.
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