Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
FDA Recall Z-0151-2015 · Posted 2014-10-30
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Recalling FirmJoerns Healthcare
Recall StatusTerminated
Product CodeFNL
Date Initiated2014-09-24
Date Terminated2016-02-01
Product Quantity3135
Reason for Recall
The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal.
Firm Action
Joerns sent an Urgent: Medical Device Correction letter dated September 24, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm will provide the customers with a temporary solution kit to safegard the bed until a replacement Care-Lock assembly can be shipped and installed. Customers were instructed to complete the response form. For questions call 800-826-0270.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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