Events

Recall of Device Recall Draeger Medical Systems Infinity Acute Care System (M540)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draegar Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77505
  • Event Risk Class
    Class 2
  • Event Number
    Z-2734-2017
  • Event Initiated Date
    2017-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156173
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Cockpits with revision index 06 or higher that contain 4gb ram modules may not annunciate audio or visual alarms on the cockpit and central station.
  • Action
    Draeger issued on June 6, 2017 Urgent Medical Recall letter with Addendum US serial numbers via Certified Mail addressed to Risk Manager and Director Clinical Engineering The letter instructs the consignees, if the serial number of the cockpit is on the serial number list, to remove the Cockpit from use until it can be determined whether the 4GB RAM Module is among those affected. The IACS can be used without the Cockpit and the M540 will function as the primary monitoring device once the Cockpit is disconnected. A Dr¿gerService Representative will schedule a time to inspect the Cockpit and, if necessary, replace the 4GB RAM Module. The inspection and 4GB RAM replacement (if necessary) will be performed free of charge. For questions regarding the Operation and/or servicing the Dr¿ger Infinity¿ Acute Care System Cockpit contact Dr¿gerService Technical Support at 800-437- 2437 (press 4 at the prompt and then press 4 again). For OUS the responsible local Draeger Sales and Service will mail the letter with Addendum serial number list.

Device

Device Recall Draeger Medical Systems Infinity Acute Care System (M540)
  • Model / Serial
    Serial numbers: US: 401089026 401089022 401089020 401089029 401089031 401089033 401089025 401089028 401089003 401089014 401089023 401089024 401089037 401089042 401089012 401089021 401089034 401091057 401091014 401091042 401091076 401091063 404234070 404234037 404234011 404234022 404234063 404234095 404234088 404234093 404234010 404234097  OUS: 401089048 401089013 401091016 401091078 401091051 401091060 402073009 402073042 402073027 402073062 402073004 404234014 404234039 404234029 404234040 404234069 404234024 404234044 404234032 404234065 404234056 404234048 404234036 404234038 404234025 404234019 404234013 404234015 374271065 379843052 404234018 404234046 401091098 404234066 404234062 404234068 404234071 404234060 404234079 402073021 402073067 402073030 376587013 401089007 401091035 401091085 401091088 402073089 402073063 404234012 401091011 401091048 401091055 401091039 401091047 401091044 401091038 401091068 401091071 402073022 402073024 402073050 402073065 402073049 404235077 404235050 404235053 404235060 402073056 402073053 402073047 404234020 402073043 401089044 401089035 401089049 401089039 401089006 401089032 373821055 376586021 401091003 404234098 404234064 404234074 404234067 404234072 404234075 404234085 404234078 404234087 404234027 404234002 404234003 404234090 404234004 404234023 404234028 404234043 404234096 404234006 404234009 404235015 404234035 404234080 404235016 404235024 404235006 404235029 404235018 404235040 404234082 401089019 401089009 404235038 404235057 402073001 404235061 404235088 404235095 404235066 404235054 404235009 404235055 404235037 404235025 404235004 404235007 404235011 404235005 404234084 404234100 404234057 404234034 404234091 404234052 404235042 404235001 404235028 404235031 404235014 404235021 404234001 404235020 404235039 404235056 404235030 404235036 404235032 404235048 402073008 401089040 402073068 402073012 402073057 404235099 404235070 404235097 404235008 404235080 404235083 404235078 404235065 404235094 404235098 404235100 404235035 404235068 404235086 404235096 404235081 404235051 402073061 402073013 401091070 401091086 401091053 401091089 401091087 401091049 401091090 401091050 401091081 401091002 401091059 401091067 401091083 401091007 401091028 401091009 401091069 402073079 402073083 402073076 402073070 401089043 401089030 401089011 401089047 401089002 401089017 401089008 401091072 401091001 401091043 401091046 402073055 402073038 404234094 404234021 401089016 401089045 404234053 376586067 402073077 402073075 402073081 402073066 402073036 402073046 401089050 402073017 404234092 404234083 402073080 350597089 404234061 404234099 401091034 401091026 401091019 401091023 401091020 401091024 401091030 401091006 401091032 401091005 401091018 401091029 401091022 401091027 401091036 401091013 401091017 401091031 401091058 401091012 401091091 401091040 401091015 401091064 401091075 401091073 401091100 401091025 401091052 401091097 401091096 401091092 401091079 401091080 401091077 401091062 401091061 404235047 404235043 404235058 404235045 404235044 404235084 404235085 404235075 404235091 404235092 404235022 404235062 404235071 404235090 404235012 404235076 404235074 404235064 404235079 404235010 404235041 404235023 404235052 404235073 404235017 404235046 404235069 404235049 350599032 401091065 404234016 404234049 404234054 404234081 404234055 404235089 401091037 401091082 404235013 404235026 404235059 404235087 401091033 401091054 401091008 402073088 402073052 402073082 402073044 402073037 402073064 402073020 402073059 401091021 404235093 401089015 401089027 401089041 401089046 401089001 401089005 401089010 401089004 401091004 402073029 402073058 402073060 402073078 402073018 402073035 402073086 404234058 404234073 404234042 404234045 404234059 404234076 404234033 404234041 404235033 401091010 402073045 402073051 402073073 402073072 402073040 402073039 404235063 404235082 401089018 401091066 401091074 401091093 401091095 401091056 402073005 402073041 402073010 402073034 402073031 402073019 404234077 404234031 404234030 404235027 404235002 404235019 404235003 404234026 343415011 344038069 350598048 354214100 350603047 402074009 401780016 344035053 352066008 354380009 350603074 401780019 402074005 401780006 344034032 350603044 350603040_1 354380023 401780039 401780038 401780003 401780024 401780004 401780001 401780005 401780046 401780030 401780012 401780037 401780034 401780032 402074020 402074017 402074012 402074015 401780023 402074021 402074014 402074011 402074016 402074008 350602060 337018060 402074018 402074003 401780051 354380084 402074019 354380097 337018078 350603049 401780002 401780025 401780020 401780026 401780018 401780022 401780029 401780027 401780017 350602014 350602037 374270012 376595073 401780053 401780021 401780042 401780048 401780054 401780035 401780033 401780047 354380073 350603040 354380076 354380055 354380059 354380068 354380026 354380043 354380062 344035021 350602046 350603012 344035033 344035044 354380051 401780014 401780015 354380021 402074010 401780050 402074004 402074007 401780031 402074001 401780040 401780044 402074002 401780008 401780007 401780010 402074006 401780009 401780011 401780036 401780043 401780041 354380098 354379026 350603073 354380074 354380065
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom
  • Product Description
    Draeger Medical Systems Infinity Acute Care System (M540) || Catalog Numbers: MK31501/MK31701/MK31722
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • Manufacturer Address
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA