Z-2549-2019Class II

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Name: Z-2549-2019 Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Creator: Philips North America LLC
Published: 2018-08-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-08-08 / Terminated / root cause: labeling and UDI

FDA source

Philips North America LLC began a recall of Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 on 2018-08-08. FDA classified it as Class II and gives the reason as "The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2549-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Posted: 2019-09-20
Terminated: 2021-04-29
Recalling firm: Philips North America LLC
Product: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: A labeling specification for the HS1 is available against which labeling can be checked prior to design transfer and/or localization. This activity has been moved under regulatory affairs for review and maintenance.
Quantity in commerce: 181,894 Infant/Child SMART Pads Pads
Distribution: US: AK, AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, WY, Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Egypt, El Salvador, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Malta, Martinique, Mauritius, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, R¿union, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Viet Nam,
Product codes and lots: Model# M5072A; Lots #s Y070115-04 - Y011118-07;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2549-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2549-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-20

Product code MKJ

K020715Class IIIPhilips M5066a and M5068aPhilips Medical Systems / cleared 2002-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)