—#126507

Product

Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K110825
Affected lot / code info: USO1100106 to USO1100372 USN1100376 to USN1100960 USD1100961 to USD1101095 US11201096 to US11201186 US21201187 to US21201239 US31201240 to US31201537 US41201538 to US41201585 US51201586 to US51201721 US61201722 to US61201924 US71201925 to US71202048 US81202049 to US81202168 US91202169 to US91202514 USO1202515 to USO1202990 USN1202991 to USN1203537 USD1203538 to USD1203968 US11303969 to US11303972 US21303980 to US21304488 US31304489 to US31305042 US41305043 to US41305295 US51305296 to US51305450 US61305451 to US61306138 US71306139 to US71306542 US81306543 to US81306998 US91306999 to US91307261 USO1307306 to USO1307458 USN1307616 to USN1308423 USD1308424 to USD1309471 US11409472 to US11410212 US21410213 to US21410563

Why it was recalled

Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare sent an Urgent Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. Please see the attached Field Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Please follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a software upgrade to customers with affected units free of charge. This voluntary correction has been reported to the appropriate regulatory agency. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. Philips apologizes for any inconveniences caused by this problem.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the countries of: ARGENTINA AUSTRALIA AUSTRIA BELGIUM CANADA CHINA CZECH REPUBLIC DENMARK FRANCE GERMANY ITALY LATVIA NETHERLANDS NEW ZEALAND NORWAY PHILIPPINES PORTUGAL SOUTH KOREA SPAIN SWITZERLAND THAILAND TURKEY and UNITED KINGDOM.

Timeline

Recall initiated: 2014-04-02
Posted by FDA: 2014-04-09
Terminated: 2020-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.