GE Healthcare, LLC: GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

Is my product affected?

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

• UPC 00840682109666
• UPC 00840682109604

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare is recalling 10,445 units of the CARESCAPE Central Station v2.0 (both MAI700 Integrated and MAS700 Desktop models) distributed worldwide, including nationwide in the US and Puerto Rico, as well as to government and military facilities. The recall affects units with Version 2.0.x (v2.0.0, v2.0.1, v2.0.2, or v2.0.3) and specific serial number prefixes: SKN or SNF for MAI700 Integrated models, or SNF for MAS700 Desktop models.

The hazard is that if the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted, resulting in loss of audible alarms. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

Details from the source

Reason for recall: If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. Distribution: Worldwide distribution - US nationwide, including Puerto Rico. There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cote d'lvoire, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Ghana, Hong Kong, Hungar Quantity: 10,445 units Lot/code info: Version 2.0.x (v2.0.0, v2.0.1, v2.0.2, or v2.0.3) with serial numbers beginning with SKN for the MAI700 Integrated, UDI 00840682109666 and serial numbers beginning with SNF for the MAI700 Integrated, UDI 0100840682109604; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604.

Source

Official record: FDA (Device enforcement) ↗

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

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