Z-2629-2017 Class II Terminated
FDA device recall Z-2629-2017 was initiated by Olympus Corporation of the Americas on April 19, 2017 and is designated Class II. Reason for recall: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. The recall status is terminated (terminated October 1, 2018). Affected quantity: 1264 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- April 19, 2017
- Termination Date
- October 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1264 units
Product Description
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Reason for Recall
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Distribution Pattern
Nationwide Distribution
Code Information
Model: A22201C - Resection electrode, loop style Lot # 16123P03L001, 16124P03L001, 16131P03L001, 16139P03L001, 16140P03L001, 16144P03L001, 16144P03L002, 16144P03L003, 16155P03L001, 16169P03L001,16173P03L001, 16174P03L001 16174P03L002, 16223P03L001,16224P03L001,16236P03L001 P16X0001, P16X0002,P16X0003,P16X0004,P16Y0001,P16Y0002 P16Y0003,P16Y0004,P16Y0005,P16Y0006,P16Y0007,P16z0001 P16Z0002,P16Z0003,P1710001,P1720001,P1720002 Model: WA22037C - Resection electrode, loop style Lot # 16195P04L001, 16215P04L001, P16Y0001