Magstim HORIZON Ez Arm Recalled for Protruding Stainless-Steel Cable Strand
The Magstim Company Limited is recalling 27 HORIZON Ez Arm units because a stray stainless-steel cable strand may protrude from the heat shrink sleeving on the Balance Cable.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (protruding cable) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Magstim Company Limited is recalling 27 units of the HORIZON Ez Arm, which is part of the HORIZON TMS Therapy System. The recall is due to a potential defect where a stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable.
The affected units are distributed in California, Massachusetts, Minnesota, Pennsylvania, Texas, Virginia, Wisconsin, and Washington. The recall includes 27 units, including 2 demos, identified by specific product and serial numbers listed in the agency documentation.
Consumers and healthcare providers should stop using the affected HORIZON Ez Arm units and contact The Magstim Company Limited for further instructions on the recall.
The recalled product
- Product
- HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
- Manufacturer
- The Magstim Company Limited
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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