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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger Infinity CentralStation

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  Class 2 Device Recall Draeger Infinity CentralStation see related information
Date Initiated by Firm April 05, 2023
Date Posted April 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1471-2023
Recall Event ID 91938
510(K)Number K151860  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Code Information UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information Contact Mike Kelhart
267-664-1131
Manufacturer Reason
for Recall		 The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
FDA Determined
Cause 2		 Software design
Action An Urgent - Medical Device Correction notification letter dated March 2023 was sent to customers. Actions to be taken: Until the corrected software is available and installed, clinicians should utilize the Draeger ICS/MSOO Instructions For Use while applying any additional means of standard practices for assessment of patients with unusually high and/or low QRS amplitudes. Clinicians should combine this information with physical assessment of the patient and follow standard clinical practice. Please ensure that all users of the affected products listed above and other people within your organization are made aware of this Important Safety Notice. If you have provided the products to third parties, please forward a copy of this information to them. Actions being taken by the Company: We are currently working on releasing updated software (ICS VG4/M300 VG3) to resolve the issue which will be provided to you at no charge; targeted for the third quarter of 2023. Your local Drager Service representative will contact you to arrange a date for the software update to be performed once the software is available. Please keep this information at least until the software update has been completed. Please also complete and return the Customer Acknowledgment Card provided to confirm to us that you have received this information. We regret any inconvenience this may cause. We consider this notice a necessary measure to increase patient safety. We thank you for your support. If you have any questions regarding the operation of the Product, please contact Drager Service Technical Support between the hours of 8:00 AM - 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1). An Urgent - Medical Device Correction UPDATE TO: Urgent - Medical Device Correction released March 2023 relating to software on the Infinity CentralStation dropping peaks on narrow waveforms causing the Infinity¿ M300 to fail clauses 201.12.1.101 and 201.12.1.101.8 within IEC 60601-2-27 Frequ
Quantity in Commerce 6803 systems
Distribution Worldwide - US Nationwide distribution.
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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