Recall Record

Amersham, United Kingdom

THOR Photomedicine Ltd recalls

3 recalls recorded since 2018, most recently on 24 July 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
24 July 2025
Reason
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Distribution
Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2419-2025, Z-2417-2025, Z-2418-2025, Z-2416-2025

Ongoing Class II Medical devices

Recall started
20 November 2023
Reason
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
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.
Initiated
Voluntary: Firm initiated
Recall number
Z-0972-2024

Ongoing Class II Medical devices

Recall started
13 September 2022
Reason
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Distribution
Worldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, West Virginia. OUS (foreign) to countries of: Australia,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0455-2024, Z-0453-2024, Z-0454-2024, Z-0456-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.