FDA (Devices) recall action 79493
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling 28 Datex-Ohmeda TEC 7 anesthesia vaporizers shipped from a service center without proper evaluation, potentially making them nonconforming.
GE Healthcare is recalling two Datex-Ohmeda AISYS CS2 Aladin2 cassettes because they were shipped without proper evaluation and may be nonconforming.