Recall Z-0245-2023 ยท FNG Lift, Patient, Ac-Powered
Tollos
Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
| Date | Nov 17, 2022 (initiated Oct 24, 2022) |
| Status | Open, Classified |
| Reason | Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s). |
| Root cause | Equipment maintenance |
| Action | On October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. The firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed. Access complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins. Tollos can be contacted by e-mail at service@tollos.com. |
| Quantity | 1273 US; 70 OUS |
| Distribution | Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.