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Umano Medical Inc · Model 200-0000 · UDI-DI 00670482000227

FNL

510(k) clearances

93,774

Adverse events (647 deaths)

155

Recalls

235

Facilities

Description

AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustment of the height and surface contours. Bed includes movable and latchable siderails or patient mobilization helper, and control boards. The patient sleep surface can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The surface width can be manually extended from 35” up to 47”. The product offers a range of options and accessories including but not limited to integrated scale, integrated bed exit system, bed status monitoring, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.

Recalls

Date	Firm	Reason
2026-05-04	KAYSERBETTEN GMBH & CO. KG	If 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
2024-09-18	Baxter Healthcare Corporation	The 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
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30	Stryker Medical Division of Stryker Corporation	Patient 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.