Product Safety Recalls

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Draegar Medical Systems, Inc. Recall 89877

Description: Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

Draegar Medical Systems, Inc. Recall 89877 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1012-2022
Event ID89877
Event DescriptionDrager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.
Quantity1950 (1574 OUS + 376 US)
Recall ReasonSoftware issue resulting in temporary loss of central monitoring functionality.
Device Classification20220504
Device Code InfoUnique Device Identifier (UDI) for US distribution: (01)04049098001878(11)200626(21)1OQ84F-01013(93)MS26800-40, (01)04049098001878(11)190516(21)1OQ80D-00211(93)MS26800-36, (01)04049098001878(11)191218(21)1OQ84F-00362(93)MS26800-37, (01)04049098001878(11)200323(21)1OQ84F-00617(93)MS26800-38, (01)04049098001878(11)190903(21)1OQ84F-00103(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00105(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00104(93)MS26800-37, (01)04049098001878(11)190903(21)1OQ84F-00099(93)MS26800-37, (01)04049098001878(11)190807(21)1OQ84F-00065(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00081(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00120(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00080(93)MS26800-36, (01)04049098001878(11)190807(21)1OQ84F-00070(93)MS26800-36, (01)04049098001878(11)200630(21)1OQ84F-01005(93)MS26800-40, (01)04049098001878(11)190730(21)1OQ80D-00059(93)MS26800-36, 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Additional US Serial Numbers (w/o UDI): 12946M00316, 12946M00314, 12946M00269, 11553M00212, 11516M00186, 12051M00467, 11516M00155, 11516M00359, 11553M00646, 11097M00482, 12381M00904, 12381M00952, 11097M00313, 11407M00119, 11097M00661, 12051M00327, 11731M00246, 11731M00230, 11731M00245, 11516M00314, 11802M00360, 11553M00190, 11407M00061, 12381M00513, 12381M00557, 11187M00009, 12051M00412, 12381M00528, 12051M00381, 12381M00551, 12381M00566, 12381M00478, 12381M00505, 12381M00500, 11553M00883, 12381M00473, 12381M00464, 12381M00531, 11097M00451.
Center Classification Date20220427
Recall Initiation Date20220304
Recalling FirmDraegar Medical Systems, Inc.
Initial Notification Letter
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