Recall Z-2236-2023 ยท IKK System, Isokinetic Testing And Evaluation
Trexo Robotics Holdings Inc.
Trexo Device
| Date | Jul 25, 2023 (initiated May 31, 2023) |
| Status | Open, Classified |
| Reason | Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use. |
| Root cause | Device Design |
| Action | The firm distributed recall notification to customers by email on 5/31/2023. This notification asks that customers not expose the device to rain or spilled liquids, not store the device outdoors, wear pants to cover exposed skin to minimize the effect of hot surfaces, and if experiencing any electrical interference or difficulty operating another device in the vicinity of a Trexo device move away and and/or turn off the Trexo Device. Affected devices will be subject to a correction which will be carried out by technician; technician appointments will be scheduled once customers reply to the re |
| Quantity | 357 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of the Argentina, Australia, Brazil, Canada, China, Croatia, Czech Republic, England, Germany, India, Kuwait, Mexico, Poland, Qatar, Republic of Cyprus, Serbia, Singapore, Slovakia, Spain, United Arab Emirates, and Yemen. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.