(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC i

FDA device recall Z-0731-2024 · posted 2024-01-13 · Open, Classified

Recall details

Recalling firm

Philips North America

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

MHX

Quantity affected

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,

Date initiated

2023-11-28

Date posted

2024-01-13

Location

Cambridge, MA

Related 510(k) clearances