Class II — CLINICAL LASERTHERMIA SYSTEMS AB
| Recalling firm | Clinical Laserthermia Systems AB |
|---|---|
| Registered facility | CLINICAL LASERTHERMIA SYSTEMS AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | single use devices labeled as sterile may not have been adequately sterilized |
| Product | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg® MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue. |
| Quantity | 40 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland. |
| Initiated | 2021-04-01 |
| Classified | 2021-06-03 |
| Terminated | 2023-08-30 |
| Recall number | Z-1780-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CLINICAL LASERTHERMIA SYSTEMS AB (Z-1780-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87808/
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