FDA (Devices) recall action 98133
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of th…
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 3 units of the SMV DSI nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Gold Star Distribution is recalling Advil products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
GE HealthCare is recalling 7 units of the SMV DSX New Line nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Gold Star Distribution is recalling Motrin 2's dispensers over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.