Class 2 Device Recall HeartStart XL

• Date Initiated by Firm: June 11, 2007
• Date Posted: August 07, 2007
• Recall Status: Terminated on August 08, 2016
• Recall Number: Z-1128-2007
• Recall Event ID: 38239
• 510(K)Number: K021453
• Product Classification: Defibrillator/Monitor - Product Code MKJ
• Product: Philips Medical HeartStartXL Defibrillator/Monitor; Model : M4735A
• Code Information: Serial Numbers: US00453441 through US00453910
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Road; Andover MA 01810-1032
• For Additional Information Contact: Same as contact; 978-687-1501
• Manufacturer Reason for Recall: The ECG signal may become unusable to assess patient condition and need for therapy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
• Quantity in Commerce: 312 units
• Distribution: Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
• 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