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Draeger Medical Systems, Inc. FDA Recalls

6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitorClass IIJan 14, 2025Edifier speakers (shipped in or after April 2023) may not an
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23Class IIMay 13, 2024Device is not in full compliance to Type CF requirements of
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1Class IIMay 16, 2023The Resuscitaire Infant Radiant Warmer with the optional sca
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hClass IIApr 5, 2023The software on the Infinity CentralStation drops peaks on n
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatoryClass IIApr 5, 2023The software on the Infinity CentralStation drops peaks on n
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport systemClass IIMay 20, 2022The firm has initiated this recall to replace component on d

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