—#104146

Product

GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

FDA product code: IWE — Monitor, Patient Position, Light-Beam
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: 5147788-5, 5139394, and 5139394-2; 2199859 and 2202900-6; 5148810 and 5373011; 5148810-2 and 5373011-2; 5148810-3, 5148810, and 5373011.

Why it was recalled

GE Healthcare has become aware of missing labels on the alignment lasers.

Root cause (FDA determination)

Labeling design

Action the firm took

GE Healthcare will execute a field action in which GE Healthcare Field Engineers will perform an inspection of all suspect MR systems. Any systems lacking any of the 3 laser warning labels will be remediated by applying the missing labels). We expect this field action will be completed by June 30, 2012. 1. Notification of all distributors and purchasers be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. The FDA district office coordinator noted below is to be included in the notifications. 2. Corrections be made at no cost to the purchasers.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-09-15
Posted by FDA: 2012-02-08
Terminated: 2012-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.