Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84850

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America LLC

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

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 2

Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

Z-1271-2020
Recall number
Z-1271-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Philips North America LLC
Quantity
44 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

Code information

Model: 861304 Software Version: FRx codeRev: E.02.017 System Serial Numbers: B17G-05063 B17C-03662 B17D-00167 B16G-06056 B16J-03182 B16J-03349 B14J-00603 B15E-08588 B15G-03528 B16A-00186 B16A-00189 B16A-00235 B16J-01934 B17G-02322 B17G-02937 B17I-00135 B18E-01082 B16L-03105 B15L-01146 B14H-00561 B17D-00056 B18E-01975 B16K-02837 B16E-01325 B16E-01627 B15E-06814 B15L-07200 B16K-03381 B13G-04020 B17F-02048 B17I-08789 B14I-00249 B15G-02703 B16E-01403 B16E-00725 B16F-04894 B16J-06377 B16G-05481 B16K-03980 B17F-07414 B17H-05164 B17I-07486 B16C-00187 B17D-00228

Distribution pattern

HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan

device · product 2 of 2

Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063

Z-1272-2020
Recall number
Z-1272-2020
Initiated
September 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Philips North America LLC
Quantity
Total 96 units = 95 units (HS1 Onsite) and 1 unit (HS1 Home)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

Code information

HeartSmart HS1 Onsite Model: M5066A Software Version: FRx codeRev: E.03.063 System Serial Numbers: A18B-01564 A18B-05110 A15F-00203 A15F-00836 A16A-05193 A18B-01898 A18B-04580 A18C-06368 A18C-13087 A14J-05349 A17G-04454 A16F-05540 A16H-00179 A16I-05335 A15C-06311 A18B-01163 A14E-01309 A14H-00385 A14H-03858 A14J-06953 A15B-02135 A15I-00313 A15J-02119 A15J-03499 A16A-00020 A16A-04110 A16D-02839 A16E-00092 A16E-00321 A16E-01139 A16H-01715 A16H-03269 A16H-03289 A16H-03295 A16H-03388 A16I-01108 A16I-01192 A16J-03827 A16K-09220 A16K-09284 A16K-09350 A16L-08039 A17D-02967 A17E-06623 A17L-05540 A18B-06555 A16B-01360 A16J-04476 A16F-05541 A16K-06215 A17F-05535 A17G-01106 A18B-05091 A16L-03891 A18D-00634 A14I-05831 A14I-06556 A14J-04548 A15H-01226 A15H-04421 A16B-05332 A16E-01367 A16F-01716 A16H-01397 A16H-02511 A16I-01557 A16I-01570 A16I-01572 A16I-01819 A16I-01992 A16I-02579 A16I-03774 A16I-08781 A16I-09247 A16I-09253 A16I-09345 A16K-02763 A17F-01602 A17F-02212 A17F-07151 A17I-06611 A17K-05176 A17L-12513 A17L-13149 A17L-13954 A17L-14968 A18A-00046 A18B-12050 A18C-12844 A18C-13301 A18C-13490 A18C-15686 A18C-16215 A18C-16221 A18C-16224 A18C-16236

Distribution pattern

HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan