PlainRecalls
FDA Devices Moderate Class II Ongoing

NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

Reported: February 7, 2024 Initiated: November 20, 2023 #Z-0972-2024

Product Description

NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

Reason for Recall

One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy

Details

Recalling Firm
THOR Photomedicine Ltd
Units Affected
61 (41 US; 20 OUS)
Distribution
Domestic distribution to the states of Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Maryland New Jersey New York Oregon Pennsylvania Texas Washington Wisconsin. Foreign distribution to Australia, Canada, Italy, Malta, Norway, Switzerland, UAE, and UK.
Location
Amersham

Frequently Asked Questions

What product was recalled?
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL. Recalled by THOR Photomedicine Ltd. Units affected: 61 (41 US; 20 OUS).
Why was this product recalled?
One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0972-2024.