Recall Z-2418-2020 ยท IKK System, Isokinetic Testing And Evaluation
Hocoma AG
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-
| Date | Jun 23, 2020 (initiated Jun 8, 2020) |
| Status | Open, Classified |
| Reason | The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way. |
| Root cause | Device Design |
| Action | The firm began notifying affected customers on June 8, 2020. Customers were informed that the motor-controller in their Lokomat may fail, potentially leading to an unintended error in functionality of the Body Weights Support Rope which means that the rope can go up or down in an uncontrolled way. To minimize a risk in relation to a potential failure of the motor-controller, the firm advises you to do the following: - As indicated in the Instruction for Use, permanently monitor patients, which perform a training with the Lokomat. The scenario is especially critical for pediatric patients. - I |
| Quantity | 494 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, MN, MO, NE, NY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.