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Defibtech Sentry Semi-Automatic External Defibrilator (AED)… recallZ-0580-2007 · Defibtech, LLC · initiated Feb 17, 2007

Terminated All recalls posted in March 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Defibtech, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

FDA root cause category: Software design

What the company is doing

Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded. Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their customers, and direct accounts shall return to Defibtech documentation confirming unit software upgrade was completed..Press was issued by the firm on March 6, 2007

Recall details

Recall number
Z-0580-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 17, 2007
Posted by the FDA
Mar 8, 2007
Recalling firm
Defibtech, LLC
Quantity
22,197 units
Product code
MKJ
FDA submissions
K013896
Distribution
Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.

Product description

Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)

Code information (models, lots, serial numbers)

Model DDU 100A-Software versions earlier than version 2.002

Other devices under the same FDA submission

10 devices cleared under K013896 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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