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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 14 Results
510(K) Number: K103142
 
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GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service ... 2 05/28/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexP... 2 05/28/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; ... 2 05/28/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Produ... 2 05/28/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction w... 2 05/28/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Nu... 2 05/01/2026 FEI # 3010157426
Spacelabs Healthcare, Inc.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor 2 04/07/2026 FEI # 3010157426
Spacelabs Healthcare, Inc.
Ultraview SL (UVSL) Command Module, Model 91496 2 05/03/2023 FEI # 3010157426
Spacelabs Healthcare, Inc.
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Tempe... 2 08/04/2016 FEI # 3010157426
Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Space... 2 05/04/2015 FEI # 3010157426
Spacelabs Healthcare Inc
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