GE Healthcare ($GE) is confronting more manufacturing problems with components used in Giraffe and Panda infant warmers.
The latest: The company is under way with a "voluntary field corrective action" regarding the field upgrade kit for the company's resuscitation systems with blender, which are installed in both products. GE says patients could be at risk because the oxygen and air wall inlet fittings and/or their labels on the back panel could have been reversed during assembly. The risk is that the goof could reverse air/oxygen mixer concentrations, making the blender knob settings inaccurate.
GE's voluntary move comes as the company is recalling malfunctioning T-piece circuits used in both the Giraffe and Panda devices, which GE said could lead to insufficient inspiratory pressure, putting patients at risk.
For the latest action, GE has been notifying customers since October through a letter that instructs hospital personnel how to inspect and deal with the device. And the company said its field service engineers have been pursuing ongoing follow-up, though no patients have yet been injured. GE says it produced the affected resuscitation system upgrade kits from April 2008 through September 2012, and that the FDA classified the problem as a Class I recall--its most serious.
In late December, GE disclosed its Class I recall involving T-piece circuits from both devices, affecting lots manufactured between September 2009 and May 2012.
- read the release
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