Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE

• Date Initiated by Firm: February 04, 2022
• Date Posted: April 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0881-2022
• Recall Event ID: 89672
• PMA Number: P160029
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
• Code Information: ALL LOTS
• Recalling Firm/ Manufacturer: Philips North America LLC; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
• FDA Determined Cause: Under Investigation by firm
• Action: On March 4, 2022, Philips mailed an Urgent Medical Device Correction notification. On December 14, 2022, Philips issued an Urgent Medical Device Correction - Expansion notification, dated November 15, 2022. The recall was expanded to notify customers who received an HS1/OnSite/Home AED more than 10 years ago. 1. Keep your HS1/OnSite/Home AED in service until you receive updated pads. If you need to use your HS1/OnSite/Home AED before receiving updated pads cartridge, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. If the gel begins to separate from the white foam backing as you peel, try to prevent the gel from folding onto itself. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing. 2. In case of trouble, install a spare pads cartridge and continue the rescue. No matter the state of the pads, follow the voice prompts as the HS1/OnSite/Home AED will guide you through the needed actions. If there is no spare pads cartridge, attend to the patient, providing CPR if needed, until EMS Personnel arrive. Store a spare pads cartridge with your HS1/OnSite/Home AED. 3. Unexpired M5071A Adult pads cartridges with a LOT number that begins with Y are eligible to be replaced with an updated Adult pads cartridge, free-of-charge. You must respond to receive any free-of-charge updated Adult pads cartridges. 4. Pass this notice to all those who need to be aware in your organization or to anywhere HS1/OnSite/Home AED devices or pads cartridges have been transferred. Keep a copy of this letter with the IFU/Owners Manual. 5. A similar notice was previously sent to customers who purchased HS1/OnSite/Home AEDs less than 10 years ago. If you received that notification, please respond to both notifications. For further information or support, contact your Philips representative.
• Quantity in Commerce: 1,696,047
• Distribution: Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam.
• Total Product Life Cycle: TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.