FDA Medical Device Recalls (openFDA)
Philips North America LLC: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
- Recall number
- Z-2549-2019
- Recalling firm
- Philips North America LLC
- Product
- Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
- Status
- Terminated
- Initiated
- 2018-08-08
- Posted
- not on file
- Terminated
- 2021-04-29
- Reason
- 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
- 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
- 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,
- Lot, serial or model codes
- Model# M5072A; Lots #s Y070115-04 - Y011118-07;
- 510(k) numbers
- ["K020715"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28