Device product
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
Z-0245-2023
Product summary
- Firm
- Tollos
- Event
- Event 91000
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1273 US; 70 OUS
- Official record key
device-enforcement:Z-0245-2023
Official wording
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).
Code information: UDI-DI 00817956021 (not yet uploaded to GUDID)
Distribution pattern: Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
Derived failure modes
-
Unknown
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).