Class 2 Device Recall HeartStart MRx

• Date Initiated by Firm: November 23, 2018
• Create Date: December 13, 2018
• Recall Status: Terminated on September 29, 2020
• Recall Number: Z-0603-2019
• Recall Event ID: 81443
• 510(K)Number: K051134
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
• Code Information: UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
• Recalling Firm/ Manufacturer: Philips North America LLC; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: 1800-722-9377
• Manufacturer Reason for Recall: Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 11/23/2018 Urgent Medical Device Recall notices were mailed via USPS certified mail to customers. Customers were instructed to do the following. Inspect the batteries installed in your monitor/defibrillator to determine if they are affected by this recall. If any affected batteries are found, remove them from service immediately, along with any other affected batteries in your inventory. Further, customers were asked to complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recall.response@philips.com. Your monitor/defibrillator can only be returned to service once a charged battery, unaffected by this recall, is installed. Firm will replace affected Rechargeable Lithium-Ion Batteries at no charge to the customer. Firm will contact you when replacement batteries are available. Customers with additional questions are encouraged to call 1-800-722-9377. Distributors were advised to send a copy of the Urgent Medical Device Recall notice and Customer Reply form to any customer to whom they have distributed affected batteries.
• Quantity in Commerce: 1880 Batteries
• Distribution: U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, Estonia, Belgium, Portugal, Korea, Republic of, Argentina, India, Puerto Rico, Qatar, Netherlands, Mexico, South Africa, Ireland, Saudi Arabia, New Zealand, Bolivia, Costa Rica, Chile, Canada, Russian Federation, Slovenia
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS