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U.S. Department of Health and Human Services

Class 2 Device Recall Lifeline VIEW AUTO

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 Class 2 Device Recall Lifeline VIEW AUTOsee related information
Date Initiated by FirmMarch 18, 2025
Date PostedApril 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1694-2025
Recall Event ID 96653
PMA NumberP160032 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductAutomated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
Code Information UDI-DIs; 00815098020195 (DDU-2200, export version), 10815098020192 (DDU-2200, export version (configuration level)); Lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, 400149090,
FEI Number 3003521780
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd Ste 201
Guilford CT 06437-2714
For Additional Information ContactDefibtech Customer Service
203-453-6654
Manufacturer Reason
for Recall		It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
FDA Determined
Cause 2		Process control
ActionOn March 18, 2025 URGENT FIELD SAFETY NOTICE letters were sent to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Locate and verify the SN affected by this Field Notice listed below. The serial number is located at the back of the Lifeline View Fully Automatic Defibrillator. 3. Please complete the attached Customer Reply Form and email the form to FA2025- 01@defibtech.com. 4. Once the Customer Reply Form is received, Defibtech will contact you to arrange disposition based on your selection. Your device will be refunded or replaced at no cost to you. If you have questions now, please feel free to contact us using the email address: FA2025-01@defibtech.com. Defibtech is committed to ensuring our products meet the highest quality standards and that our customers are fully supported. I sincerely apologize for any inconvenience this may cause you. As always, Defibtech Customer Support is available by calling 1-877-453-4507, 7:30 A.M. to 6:00 P.M. (Eastern Standard Time), Monday - Friday. Thank you for your attention and cooperation.
Quantity in Commerce13 units (OUS only)
DistributionOUS only: Switzerland.
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = MKJ
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