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GE Healthcare · MRSignaOvation

What are the Details of the Customer Letter about the Signa OpenSpeed and Signa Ovation Lateral Table Adjustment Crank H…

What are the Details of the Customer Letter about the Signa OpenSpeed and Signa Ovation Lateral Table Adjustment Crank Handle.Details of the Customer Letter about the Signa OpenSpeed and Signa Ovation…

Symptom

What are the Details of the Customer Letter about the Signa OpenSpeed and Signa Ovation Lateral Table Adjustment Crank Handle. See Long Description What are the details of the customer letter about the Signa OpenSpeed and Signa Ovation Lateral Table Adjustment Crank Handle? Customers are being sent a letter from GE Healthcare with the subject as shown below. They've been asking service personnel questions about this letter. Service personnel need to know these details now to be prepared with answers. A copy of the complete letter (for reference only) is attached to the Resolution concept. This is for GE internal use only. Do not distribute. Urgent Medical Device Correction RE: Signa OpenSpeed and Signa Ovation Lateral Table Adjustment Crank Handle. GE Healthcare has become aware of an issue associated with the lateral table adjustment crank handle on your Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR system patient tables that may impact patient safety. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions . Safety Issue: The lateral table adjustment crank handle contains ferrous material. If the crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury. There have been no adverse events reported to GE Healthcare. Affected Product Details Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR Systems with adjustable tables.

Applies to

Models
Signa, Ovation
Product
Open Speed with EXCITE For HFO4 and HFO5 only
Software
OPENMR4-HFO4 Software version for HFO4 system, which is OpenSpeed with Excite Technology
Area
MR

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