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Olympic Warm-Lamps

NATUS MEDICAL INCORPORATED · Model Model 41 · UDI-DI 00382830005470

ILY
1
510(k) clearances
294
Adverse events (4 deaths)
20
Recalls
498
Facilities

Description

The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are out of the bassinet for examination, bathing, weighing, feeding, or minor procedures.Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.

Recalls

DateFirmReason
2026-01-09Technological Medical Advancements LLCSoftware update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthri
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-02-12MITO RED LIGHT INCThe near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
2023-11-20THOR Photomedicine LtdOne 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
2022-09-13Thor Photomedicine LtdFailure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13Thor Photomedicine LtdFailure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13Thor Photomedicine LtdFailure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.