openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Customers were not notified of previous recalls associated with various defibrillator models.
Code information
Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514
Distribution pattern
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
device · product 2 of 4
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Customers were not notified of previous recalls associated with various defibrillator models.
Code information
Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918
Distribution pattern
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
device · product 3 of 4
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Customers were not notified of previous recalls associated with various defibrillator models.
Code information
Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517
Distribution pattern
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
device · product 4 of 4
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Customers were not notified of previous recalls associated with various defibrillator models.
Code information
Affected serial numbers for Model # M5066A: A11K-03264, A07A-01278, B07F-01268, A10G-05443, A06E-00929, A06L-01867, A06L-01678, A07J-05837, A10C-03623, M5066A-ABD, A07K-02685, A09H-03908, 0205142344, Expansion - additional serial numbers for Model # M5066A: A11K-08837, Affected Serial numbers for Model # M5067A: A06K-02421.
Distribution pattern
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
