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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger Medical Systems Infinity Acute Care System (M540)

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  Class 2 Device Recall Draeger Medical Systems Infinity Acute Care System (M540) see related information
Date Initiated by Firm June 06, 2017
Create Date July 14, 2017
Recall Status1 Open3, Classified
Recall Number Z-2734-2017
Recall Event ID 77505
510(K)Number K113798  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Draeger Medical Systems Infinity Acute Care System (M540)
Catalog Numbers: MK31501/MK31701/MK31722
Code Information , 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.
Recalling Firm/
Manufacturer
Draegar Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information Contact Dhaval R. Trivedi
978-379-8000
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 37 US and 682 OUS
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = Draeger Medical Systems, Inc.
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