Home › Umano Medical Inc › Florence bed

Florence bed

Umano Medical Inc · Model FL23SE · UDI-DI 16704820000042

FNL

510(k) clearances

93,774

Adverse events (647 deaths)

155

Recalls

235

Facilities

Description

AC-powered hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latch able siderails.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.