Recall archive / FDA device enforcement
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 ... — FDA record Z-1012-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
- Reason
- Software issue resulting in temporary loss of central monitoring functionality.
- Classification
- Class II
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 1950 (1574 OUS + 376 US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1012-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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)04049098001878(11)190902(21)1OQ84F-00098(93)MS26800-36, (01)04049098001878(11)200911(21)1OQ84F-01196(93)MS26800-41, (01)04049098001878(11)200123(21)1OQ84F-00496(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00483(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00507(93)MS26800-37, (01)04049098001878(11)200123(21)1OQ84F-00480(93)MS26800-37, (01)04049098001878(11)191217(21)1OQ84F-00364(93)MS26800-38, 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The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
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Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Mar 4, 2022
- Center classification date
- Apr 27, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.