CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and

FDA device recall Z-1265-2022 · posted 2022-06-13 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.

Action taken

The recalling firm issued letters flagged URGENT MEDICAL DEVICE CORRECTION dated 5/10/2022 via traceable means. The letter listed the affected product details and described the safety issue and actions to be taken by the customer/user. It said they can continue to use the CSCS V2 to monitor patients on the CARESCAPE Network. In the event there is a loss of patient monitoring at the CSCS V2, they were to follow the safety instructions, which included: Ensure all patients are adequately monitored using other GE Central Stations, with alternate monitoring devices, or with increased patient surveillance. If additional GE Healthcare Clinical Information Center (CIC) or CARESCAPE Central Station devices are available in the same care unit, unmonitored patients will be automatically assigned to any open, unlocked Multi-Viewer patient windows. If there are not enough Multi-Viewer patient windows, other GE Central Stations in the same care unit will provide a list of unmonitored patients at the top of the Multi-Viewer display. Unmonitored patients can also be viewed on and assigned to any GE Central Station connected to the CARESCAPE Network in a different care unit, and the methods for doing this were described. The customer is referred to the Managing Patients chapter of their Clinical Information Center (CIC) or CARESCAPE Central Station (CSCS) User Manual for more information regarding patient viewing. The letter informed the customer that GE Healthcare will correct all affected products when the correction is available. A Medical Device Notification Acknowledgement Response Required form was enclosed to be completed and returned within 30 days from receipt by scanning or taking a photo of the completed form and emailing it back to the firm. The form is to confirm receipt and understanding of the Correction Notice. UPDATE: On 2/6/2023, the recalling firm issued an amended recall letter dated 2/6/2023 informing the consignee they were now including certain Fi

Root cause

Process control

Status

Open, Classified

Product code

DXJ

Quantity affected

30,993 Central Stations and 2,180 FRUs and displays

Distribution

Worldwide distribution - US Nationwide. There was also military/government distribution and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bos

Date initiated

2022-05-10

Date posted

2022-06-13

Location

Waukesha, WI

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