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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm August 17, 2023
Date Posted September 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-2608-2023
Recall Event ID 92992
510(K)Number K153702  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Patient Information Center iX with Software Version Number 4.x in the following:

(1) Patient Information Center iX Product Number: 866389;
(2) Patient Information Center iX Expand Product Number: 866390;
(3) PIC iX Essentials Product Number: 867093;
(4) PIC iX Essentials Expand Product Number: 867154

Code Information UDI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		 Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips issued Urgent field Safety Notice to to U.S. customers via certified mail on 8/17/23. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: If central monitoring is disrupted and blank screen displays: 1) Initiate local downtime procedures to evaluate patients at bedside and confirm local monitoring devices continue to monitor. 2) Manually reboot PIC iX to continue central monitoring This notice should be passed on to all those who need to be aware within your organization or to any organization where PIC iX 4.x devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will install a software patch to your device. The patch will add defensive mitigations to force an automatic resumption of central patient monitoring without manual intervention. If central monitoring is disrupted and blank screen displays: 1) Initiate local downtime procedures to evaluate patients at bedside and confirm local monitoring devices continue to monitor. 2) Manually reboot PIC iX to continue central monitoring This notice should be passed on to all those who need to be aware within your organization or to any organization where PIC iX 4.x devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will install a software patch to your device. The patch will add defensive mitigations to force an automatic resumption of central patient monitoring without manual intervention. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377.
Quantity in Commerce 960 units
Distribution Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark Finland France Germany Greece India Ireland Italy Japan Jordan Kenya Kuwait Lebanon Lithuania Netherlands Norway Poland Portugal Qatar Romania Slovakia South Africa South Korea Spain Sweden Sweden Switzerland United Kingdom Utd.Arab.Emir. Uzbekistan
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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