Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. ---
FDA device recall Z-0928-2012 · posted 2012-01-29 · Terminated
Recall details
- Recalling firm
- Vision-Sciences, Inc.
- Reason for recall
- Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
- Action taken
- Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EOB
- Quantity affected
- 1618 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-12-27
- Date posted
- 2012-01-29
- Date terminated
- 2018-07-06
- Location
- Orangeburg, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISION SCIENCES FLEXIBLE ENT SCOPE (K100125) | Vision-Sciences, Inc. | 2010-02-25 |
| VISION-SCIENCES ENT-3000 SCOPE (K050972) | Vision-Sciences, Inc. | 2005-04-29 |