GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
Reason for recall: GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury. Distribution: Worldwide - US Nationwide distribution. Quantity: 23430 units Lot/code info: UDI-DI: 010084068211686221; Serial Numbers: TAB24430068SA TAB24430069SA TAB24430070SA TAB24430071SA TAB26011006SA TAB26011009SA TAB26021001SA TAB26061022SA TABW63370 TAB24300033SA TABV60214 TABW63378 TAB24240010SA TABV62327 TABA70043 TABA70053 TABA70054 TABA70055 TABZ72515 TABV60081 TABV60219 TABV60221 TABV60223 TABV60224 TAB25351023SA TAB25501502SA TAB25501503SA TAB25501530SA TAB25501531SA TAB26021501SA TAB26021503SA TAB26101502SA TAB26101503SA TAB26101507SA TAB26101509SA TAB26101510SA TAB26101511SA TAB26101512SA TAB26101513SA TAB26101515SA TAB26101516SA TAB26101517SA TAB26101519SA TAB26101520SA TAB26101521SA TABX63854 TABX63855 TABX63856 TAB25111019SA TAB24160010SA TABY70926 TABY70987 TABX63393 TAB24280002SA TABV60007 TABV60203 TABW63326 TABX62677 TABX62757 TABX63717 TABX63718 TABY71177 TAB24180045SA TAB24180046SA TAB24180047SA TAB24280001SA TAB25081073SA TAB25081074SA TABB70452 TABB70464 TABB70550 TABB70572 TABX63665 TABX63769 TABX63776 TAB24330009SA TAB24330010SA TAB24330011SA TAB24330012SA TAB24330013SA TAB24330014SA TAB24330015SA TAB24330016SA TAB24330017SA TAB24330018SA TAB24330021SA TAB24430028SA TAB25101068SA TAB25101069SA TAB25101070SA TAB25101071SA TAB25101072SA TAB25101073SA TAB25101074SA TAB25101075SA TAB25101076SA TAB25101077SA TAB25101078SA TAB25101079SA TAB25101080SA TAB25101081SA TAB25101082SA TAB25101083SA TAB25111000SA TAB25111001SA TAB25111002SA TAB25111003SA TAB25111004SA TAB25111009SA TAB25111010SA TAB25111011SA TAB25111012SA TAB25111013SA TAB25421013SA
Official record: FDA (Device enforcement) ↗
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