GE Healthcare Finland Oy: CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740

Hazard

GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

Details from the source

Reason for recall: GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected. Distribution: Worldwide distribution. Quantity: 9267 units Lot/code info: GTIN 00195278522320: a) 5865770, Serial Numbers: STN22230004HA, STN22390002HA, STN22390006HA, STN22390007HA, STN22520051HA, STN23170167HA, STN23290382HA, STN23500120HA, STN24030033HA, STN24050016HA, STN23270003SA, STN24100007SA; b) 5865770-01040169, Serial Numbers: STN22230005HA, STN22230010HA, STN22230020HA, STN22230023HA, STN22230024HA; c) 5865770-01054142, Serial Numbers: STN22290004HA, STN22290005HA, STN22290006HA, STN22290007HA, STN22290008HA, STN22290009HA, STN22290010HA, STN22290011HA, STN22290013HA, STN22290014HA, STN22290015HA, STN22290016HA, STN22290058HA, STN22290059HA, STN22290060HA, STN22300005HA, STN22300006HA, STN22300010HA, STN22300011HA, STN22300012HA, STN22300013HA, STN22300014HA, STN22300015HA, STN22300072HA, STN22300073HA, STN22300074HA, STN22300075HA, STN22300076HA, STN22300077HA; d) 5865770-01054696, Serial Numbers: STN22340026HA, STN22340028HA, STN22340029HA, STN22340031HA, STN22340032HA, STN22340033HA, STN22340034HA; e) 5865770-01054698, Serial Numbers: STN22340007HA, STN22340020HA, STN22340021HA, STN22340022HA, STN22340023HA, STN22340024HA, STN22340036HA, STN22340037HA, STN22340038HA, STN22340039HA, STN22340040HA, STN22340043HA, STN22360001HA, STN22360002HA, STN22360003HA, STN22360078HA, STN22360080HA, STN22360081HA, STN22370001HA, STN22370002HA, STN22340050HA; f) 5865770-01054721, Serial Numbers: STN22230009HA, STN22230011HA, STN22230012HA, STN22230016HA, STN22230021HA, STN22230022HA, STN22230029HA; g) 5865770-01054740, Serial Numbers: STN22290027HA,

UPC codes

00195278522320

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.