—#170311

Product

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133705, K163213
Affected lot / code info: SmartStep Option

Why it was recalled

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

Root cause (FDA determination)

Software design

Action the firm took

GE Healthcare sent a Notification letter dated October 18, 2018 to affected customers and sent a second letter dated October 30, 2018. The letters identified the affected product, problem and actions to be taken. The customers were instructed to do the following: ensure that all potential users in your facility are made aware of this notification and the recommended action, also stated: To avoid the issue, only use the 'In' button on the gantry controls and follow this required workflow: 1. Move the table back into the gantry using the 'In' button on the gantry controls . 2. Verify that the needle position is aligned using the internal laser alignment light. GE Healthcare will correct both forward production and impacted customer devices with a software update. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2018-07-12
Posted by FDA: 2019-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.