Date Initiated by Firm | February 02, 2021 |
Create Date | May 21, 2021 |
Recall Status1 |
Terminated 3 on September 20, 2022 |
Recall Number | Z-1671-2021 |
Recall Event ID |
87829 |
510(K)Number | K113125 |
Product Classification |
Detector and alarm, arrhythmia - Product Code DSI
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Product | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. |
Code Information |
Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658 |
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
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Manufacturer Reason for Recall | Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices |
FDA Determined Cause 2 | Employee error |
Action | Philips Healthcare conducted site visits on 2/02/21 by Field Service Engineer and provided the customer with RMA to return affected devices. Devices retuned affected device on RMA. Device Replacement provided. |
Quantity in Commerce | 3 units |
Distribution | Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DSI
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