Patient Information Center iX recallZ-1386-2024 · Philips North America · initiated Feb 28, 2024

Why it was recalled

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT Medical Device Correction dated 2/27/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 1. The Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status. 2. Customers should update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affecting the annunciation of custom ringtones. 3. Customers should complete the Urgent Medical Device Correction Response Form at the end of the notification to submit both their acknowledgement of this recall and confirm understanding of actions to be taken. 4. This communication should be shared with all clinical staff to review and understand. 5. Place this Urgent Medical Device Correction notification with the documentation of the Care Event and Patient Information Center iX (PlC ix) Revision 4. For Distributors: Philips is requesting customers to return a Response Form to acknowledge receipt and understanding of the Medical Device Correction and confirm that the information from this Letter has been properly distributed to all users that handle the affected product. Together with this letter we are providing a list of affected products that Philips has sold to your organization. As distributor of the affected products, we kindly request that you: Send the attached Medical Device Correction to each customer to whom you have distributed any affected product as soon as possible and no later than? days, together with the Reply Card. Perform a good faith effort to ensure Notification and Reply Form arc deliver to the customer with a minimum of three attempts, and if possible, using multiple contact methods. Actions planned by Philips to correct the problem 1, The action by Philips

Recall details

Recall number

Z-1386-2024

Status

Open, Classified

Initiated by the company

Feb 28, 2024

Posted by the FDA

Mar 27, 2024

Recalling firm

Philips North America

Quantity

257,183 Units

Product code

MHX

FDA submissions

K153702

Distribution

Worldwide - US Nationwide distribution.

Product description

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• Patient Information Center iX

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  4 recalls2 deaths24 reports
• Patient Information Center iX 4.2

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  2 recalls5 deaths79 reports
• Patient Information Center iX

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  3 recalls3 deaths11 reports

Product lines

• Patient Information Center iXPhilips Medizin Systeme Böblingen GmbH · 9 models · 406 reports · 7 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 94185).

• Z-1387-2024 · Open, Classified
  CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X