Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1438-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 2, 2014

Date Posted: April 16, 2014

Recall Number: Z-1438-2014

Event ID: 67862

Reason for Recall:

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

Status: Terminated

Product Quantity: 9872 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated