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GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is ind...

FDA Device Recall #Z-1100-2013 — Class II — April 23, 2012

Recall Summary

Recall Number Z-1100-2013
Classification Class II — Moderate risk
Date Initiated April 23, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 46

Product Description

GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body.

Reason for Recall

GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.

Lot / Code Information

Serial Number 00000000UA0027 00000000UA0012 00000000UA0029 00000000UA0031 00000000UA0030 00000000UA0028 00000000UA0034 00000000UA0038 00000000UA0048 00000000UA0046 00000000UA0052 00000000UA0041 00000000UA0011A 00000000UA0055 00000000UA0056 00000000UA0057 00000000UA0064 00000000UA0053 00000000UA0044 00000000UA0047 00000000UA0010 00000000UA0013 00000000UA0017 00000000UA0042 00000000UA0016 00000000UA0019 00000000UA0015 00000000UA0058 00000000UA0051 00000000UA0025 00000000UA0024 00000000UA0020 00000000UA0040 00000000UA0018 00000000UA0036 00000000UA0043 00000000UA0054 00000000UA0022 00000000UA0023 00000000UA0045 00000000UA0039 00000000UA0035 00000000UA0049 00000000UA0021 00000000UA0033 00000000UA0037

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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