Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

FDA Recall Z-0026-2007 · Posted 2006-10-14

Recalling FirmExtended Care Air Therapy Systems Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated2006-04-05
Date Terminated2012-09-21
Product Quantity102 beds

Reason for Recall

Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall

Firm Action

The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.

Root Cause

Other

Distribution Pattern

The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑