—#193871

Product

CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.

FDA product code: DXJ — Display, Cathode-Ray Tube, Medical
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K162012
Affected lot / code info: All CARESCAPE Central Station V2 units: (1) CSCS V2 MA1700 Integrated, Product Code SKN, Model #2082278-001, GTIN 00840682109666; (2) CSCS V2 MAS700 Desktop, Product Code SNF, Model #2082279-001, GTIN 00840682109604. NOTE: The Product Code is the first 3 letters of the serial number.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distribution - US Nationwide. There was also military/government distribution and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Kazakhstan, Kenya, Korea, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Malta, Mauritius, Mexico, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.

Timeline

Recall initiated: 2022-05-10
Posted by FDA: 2022-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193871. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.