openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
These labels are deterministic app interpretations, not FDA categories.
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Code information
Product Number: 5188-00
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
device · product 2 of 2
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
These labels are deterministic app interpretations, not FDA categories.
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Code information
Product Code: 3853-00
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CT, TN, IL, MN, MT, NC, NJ, NY, PA, SC, TX, WA, and the countries of Cyprus, China, Iran, Saudi Arabia, UK, Italy, Malaysia, Spain, Taiwan, Vietnam, Australia, Japan, Turkey, France and Israel.
