Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93723

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 20, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
THOR Photomedicine Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0972-2024
Recall number
Z-0972-2024
Initiated
November 20, 2023
Classification
Class II
Status
Ongoing
Recalling firm
THOR Photomedicine Ltd
Quantity
61 (41 US; 20 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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

Code information

(1) UDI-DI 05060494130503 Serial Numbers 4004 4009 4013 4017 4019 4021 4024 4026 4028 4029 4035 4037 4042 4043 4044 4046 4047 4048 4054 4065 4066 4072 4073 4074 4076 4077 4078 4079 4080 4081 4082 4083 4085 4086 4087 4090 4091 4096 (2) UDI-DI 05060494130527 Serial Number 4068 (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014

Distribution pattern

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.