FDA Device recall Z-1840-2019
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components…
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components… by Coopersurgical, citing 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1840-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-23 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
Reason
2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
Identifiers
| code_info | 2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,201…2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,2018110013, 2018110014, 2018110015,2018110016, 2018110017, 2018110019, 2018110020,2018110021,& 2018110022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1840-2019%22
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