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
|
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
|
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
|
|
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.
|
510(K) Database |
510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDICAL SYSTEMS
|