Recall Z-1168-2013— GE Healthcare, LLC

Name: FDA recall Z-1168-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-09

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-01-09, terminated 2013-08-06. It names 2 FDA 510(k) clearances: K080124, K051855. Product: Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.. Reason: GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-01-09
Terminated: 2013-08-06
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K080124 — VENTRI 1.1Ge Medical Systems F.I. Haifa·cleared 2008-01-31
K051855 — VENTRIGe Medical Systems F.I. Haifa·cleared 2005-08-02

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

Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.

Reason for recall

GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.

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