Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a mon

FDA device recall Z-2437-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.

Action taken

Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.

Root cause

Device Design

Status

Terminated

Product code

MQB

Quantity affected

375

Distribution

Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH,

Date initiated

2008-07-25

Date posted

2008-09-20

Date terminated

2011-12-10

Location

Waukesha, WI

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