Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended use: The Responder 2000 is indicate
FDA device recall Z-1683-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- Reason for recall
- The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing and holding down the Charge or Shock button on the Responder 2000 for more than 5 seconds causes a "Button Stuck" error. With the "Button Stuck" error, the device will automatically exit Manual mode and enter Monitor mode. The user cannot apply therapy while the device is in Monitor mode.
- Action taken
- The firm, Cardiac Science, sent an "Urgent-Medical Device Corrective Action" letter dated October 15, 2009, was sent to customers. The letter describes the product, problem and action to be taken by the customers. Cardiac Science requested GE to provide the end users with the Operator's Manual addendum. The customers are instructed to place the Operator's Manual addendum with their Responder 2000 Operator's Manual for future reference. If you have any questions about your Responder 2000, please contact Cardiac Science technical support at +44.161.926.0011 or our EU Representative, Ludger Moller, MDSS GmbH at +49.511.6262.8630.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1838 devices
- Distribution
- Worldwide distribution: USA and Australia, Brazil, Columbia, Costa Rica, Denmark, Finland, France, Germany, Italy, Korea, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Africa, Spain, a
- Date initiated
- 2009-10-15
- Date posted
- 2010-05-26
- Date terminated
- 2011-12-07
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO POWERHEART ECD (K060934) | Cardiac Science Corporation | 2006-05-15 |