FDA Medical Device Recalls (openFDA)
The Magstim Company Limited: HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
- Recall number
- Z-0836-2019
- Recalling firm
- The Magstim Company Limited
- Product
- HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
- Status
- Open, Classified
- Initiated
- 2018-10-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
- Root cause
- Nonconforming Material/Component
- Action
- On October 26, 2018, the firm sent URGENT FIELD SAFETY NOTICE, Medical Device Recall letters to their consignees to check their devices for this problem.
- Quantity
- 27 (including 2 demos)
- Distribution
- CA, MA, MN, PA, TX, VA, WI, and WA
- Lot, serial or model codes
- Product #: 5162-00 Serial #'s: 55308/001, 55308/002, 55310/001, 55310/002, 55446/001, 55446/002, 55447/001, 55447-002, 55631-001, 55631-002, 55631-003, 55631-004, 55632/001, 55632/002, 55632/003, 55632/004, 55841/001, 55841-002, 55841-003, 55841-004, 55842/001, 55842/002, 55842/003, 55842/004, 55843-001, PLT00015/001 and PLT00015/002
- 510(k) numbers
- K180907
- PMA numbers
- not on file
- Product code
- OBP
- Firm FEI
- 3002808356
- Firm city
- Whitland
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28