—#176133

Product

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

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K020715
Affected lot / code info: Model# M5072A; Lots #s Y070115-04 - Y011118-07;

Why it was recalled

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 (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Philips North America LLC
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: 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,

Timeline

Recall initiated: 2018-08-08
Terminated: 2021-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176133. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.