Recall Z-1986-2015 ยท ISD Exerciser, Measuring
BTE Technologies, Inc.
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
| Date | Jul 6, 2015 (initiated Apr 9, 2015) |
| Status | Terminated |
| Reason | On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall. |
| Root cause | Device Design |
| Action | BTE sent an Medical Device Correction letter dated April 10, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. In order to correct this issue, please immediately install the provided retrofit kit according to BTE instructions 751W2519 included in the kit. From this point on, the ring on the Chop / Lift Bar shall not be used to connect the Chop / Lift Bar to the snap hook on the 191 Tool or any other device with a snap hook. Only the Eye part of the Jaw and Eye swivel will be used to connect to the snap hook. Please |
| Quantity | 510 Devices |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, India, Japan, South Korea, Mexico, P.R. China, Poland, Republic of South Africa, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, and United |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933611 | THE BTE WS30 Baltimore Therapeutic Equipment Co., Jun 20, 1994 |