Draegar Medical Systems, Inc.: Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

Is my product affected?

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

• UPC 04049098001878

Check against the official notice below — it lists the full affected range.

What happened

Draeger Medical Systems is recalling Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12, which are used with Infinity M300 wireless telemetry devices for patient monitoring. A software issue can cause a temporary loss of central monitoring functionality. The recall affects 1,950 units distributed worldwide, including 376 units in the United States across multiple states.

The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Software issue resulting in temporary loss of central monitoring functionality.

Details from the source

Reason for recall: Software issue resulting in temporary loss of central monitoring functionality. Distribution: Worldwide 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. Quantity: 1950 (1574 OUS + 376 US) Lot/code info: Unique 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, (01)04049098001878(11)190730(21)1OQ84F-00043(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00479(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00427(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ80D-00010(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00792(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ84F-00088(93)MS26800-36, (01)04049098001878(11)190730(21)1OQ7XL-00067(93)MS26800-36, (01)04049098001878(11)200323(21)1OQ84F-00606(93)MS26800-38, (01)04049098001878(11)190830(21)1OQ84F-00110(93)MS26800-37, (01)0404

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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