Recall Z-1270-2015— GE Healthcare

Name: FDA recall Z-1270-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-27

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-01-27, terminated 2016-02-03. It names one FDA 510(k) clearance: K111116. Product: GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.. Reason: Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing)..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-01-27
Terminated: 2016-02-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000Datex-Ohmeda·cleared 2011-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.

Reason for recall

Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).

Data sourced from openFDA. This site is unofficial and independent of the FDA.