Drager Infinity CentralStation Software versions VG2.1.2… recallZ-1012-2022 · Draegar Medical Systems, Inc. · initiated Mar 4, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draegar Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue resulting in temporary loss of central monitoring functionality.
FDA root cause category: Software design
What the company is doing
A notification signed 03/08/2022, issued via certified mail on 03/11/2022 and 03/24/2022, notified customers of the impacted software versions, that a software update will be deployed to correct the issue, and provided interim instructions regarding use of USB devices. Customers are to notify all users and return the acknowledgement form. For questions please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Recall details
- Recall number
- Z-1012-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 4, 2022
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 1950 (1574 OUS + 376 US)
- Product code
- MHX
- FDA submissions
- K130711
- 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.
Product description
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Code information (models, lots, serial numbers)
Show the full code information (21k characters)
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, 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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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Infinity CentralStation Wide (confi) MS26800Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)3 recalls1 death31 reports
Other devices under the same FDA submission
4 devices cleared under K130711 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SHP UNT M300 PWT WPA2 MS25755Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall4 deaths7 reports
- INFINITY M300 Nellcor WPA2 MS26076Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 death4 reports
- Shp Unt Infinity Central Station MS18384Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)4 reports
- INFINITY M300 MS18501Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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