Philips Medical Systems Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
ABU=U.K. English, ABD=German, ABE=Spanish, ABF=French, ABH=Dutch, ABI=Hong Kong, ABJ=Japanese, ABN=Norwegian, ABO=Taiwanese, ABS=Swedish, ABX=Finland, ABZ=Italian, AB2=China, and RF=Service Replacement.
Products Sold
The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement.
Philips Medical Systems is recalling Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the due to A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
Recommended Action
Per FDA guidance
On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026