Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA device recall Z-1656-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to
- Action taken
- The firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 46740 units
- Distribution
- Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, C
- Date initiated
- 2009-04-24
- Date posted
- 2009-07-06
- Date terminated
- 2011-08-11
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |