Class 2 Device Recall Draeger Infinity M300

• Date Initiated by Firm: April 05, 2023
• Date Posted: April 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1472-2023
• Recall Event ID: 91938
• 510(K)Number: K200859
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
• Code Information: UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 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: 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: 19,429 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