| | Class 2 Device Recall Philips HeartStart Infant/Child SMART Pads Cartridge |  |
| Date Initiated by Firm | August 08, 2018 |
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| Create Date | September 20, 2019 |
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| Recall Status1 |
Terminated 3 on April 29, 2021 |
| Recall Number | Z-2549-2019 |
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| Recall Event ID |
83681 |
| 510(K)Number | K020715 |
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| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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| Product | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 |
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| Code Information |
Model# M5072A; Lots #s Y070115-04 - Y011118-07; |
| FEI Number |
1000524572
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Recalling Firm/
Manufacturer |
Philips North America LLC
22100 Bothell Everett Hwy
Bothell WA 98021-8431
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| For Additional Information Contact | Philips Customer services
1800-722-9377 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Labeling False and Misleading |
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| 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. |
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| Quantity in Commerce | 181,894 Infant/Child SMART Pads Pads |
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| 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, |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = MKJ
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