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seca 446

seca GmbH & Co. KG · Model 446 · UDI-DI 04012030021609

FRW

510(k) clearances

122

Adverse events (4 deaths)

Recalls

Facilities

Description

The guardrail is intended to prevent the clinical staff from accidentally pushing a patient's wheelchair, stretcher or bed over the side edge of a compatible scale to enable a safe weighing of patients sitting in a wheelchair or lying in a bed or on a stretcher.

Recalls

Date	Firm	Reason
2019-06-19	Seca	It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become uns
2012-12-13	Sr Instruments Inc	SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile ty
2007-12-19	Arjo, Inc.	Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.
2007-12-19	Arjo, Inc.	Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.
2007-06-13	Liko, Inc.	Sling bar may have a center bolt break at the adapter while in use
2007-06-13	Liko, Inc.	Sling bar may have a center bolt break at the adapter while in use
2007-01-30	Integrated Measurement Systems, Inc.	Patient Scale may become detached, which can cause a patient to fall and result in injury.

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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.