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ook snow MH

Umano Medical Inc · Model FL36 ook snow MH · UDI-DI 00670482000135

FNL
10
510(k) clearances
94,202
Adverse events (649 deaths)
155
Recalls
234
Facilities

Description

The ook snow MH is designed for mental health environment and is an AC-powered medical bed with 4 built‑in electric DC actuators. The height and surface contours are adjustable. The bed includes movable and latchable siderails, control boards and tamperproof fasteners. The product offers a range of options and accessories outlined in the manuals, including, but not limited to: integrated scale, bed exit system, integrated bed extender, floor fixation and, siderails and boards without openings. The expected life under normal usage and maintenance is 10 years. The ook snow MH is adapted to mental health environment and is designed for use with patients that may have special safety needs, such as patients with mental illness, for procedures, therapy and recovery in adapted health care environments, including, but not limited to, outpatient care, rehabilitation centers and, recovery or therapeutic areas. Some features, such as the adjustable power cord length, are intended for patients with special safety needs. The product can be used for patient transportation between bays and procedural rooms. The overall capacity of the bed goes up to is 600 lb. The bed is designed for the use of one single person and, to be used with a sleep surface. The patient sleep surface can be 80" long or, up to 84" or 90" with an integrated bed extender and cushion. Users are health care providers, which can use all bed operations, patient and bystanders, which can use bed motion functions, and maintenance staff.

Recalls

DateFirmReason
2026-05-04KAYSERBETTEN GMBH & CO. KGIf the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased ris
2024-09-18Baxter Healthcare CorporationThe beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

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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.