| Class 2 Device Recall Patient Information Center iX | |
Date Initiated by Firm | November 28, 2023 |
Date Posted | January 13, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0731-2024 |
Recall Event ID |
93638 |
510(K)Number | K153702 K161164 |
Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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Product | (1) Patient Information Center iX, Model No. 866389
(2) Patient Information Center iX Expand, Model No. 866390
(3) PIC iX Hardware, Model No. 866424 |
Code Information |
UDI-DI:
(1) 00884838104594
(2) 00884838112070
(3) 00884838121782
Software: PIC iX Version 4.X |
Recalling Firm/ Manufacturer |
Philips North America 222 Jacobs St Cambridge MA 02141-2296
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For Additional Information Contact | Philips Customer Services 800-722-9377 |
Manufacturer Reason for Recall | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
FDA Determined Cause 2 | Software design |
Action | On November 28, 2023, the firm notified affected consignees through URGENT Medical Device Correction letters. This failure is applicable to Apple iOS devices only.
If customers use iOS devices (e.g. iPhone, iPad, etc.) to receive event notifications:
1) Please conduct patient monitoring at the central station or patient bedside.
2) Please do not use iOS event notifications for patient monitoring.
A Philips representative will contact you to schedule a visit to install a software patch to your device
which will correct the current issue. Patch PIC iX 4.2.2 will be provided for PIC iX 4.X and patch CareEvent
C.03.07 will be provided for CareEvent C.03.X.
If you need any further information, please contact your local Philips representative, or call 1-800-722-
9377.
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Quantity in Commerce | 41 US; 773 OUS |
Distribution | Worldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN, NJ, NM, NY, OH, PA, TN, TX, WA, WV; and OUS (Foreign) distribution to countries of: Australia, Austria,
Belarus, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, India, Indonesia, Ireland, Italy, Japan, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = MHX
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