Alerta De Seguridad para Name of the product: Computed Tomography X-ray System /// Record number: 10216710193 /// Affected version (s): MX 16-Slice /// Affected batch: See attached document /// Class of risk of the product: III.

Safety alert

1882

2016-05-05

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The following problems, with risk assessment described as unacceptable by the company, and high severity were described by the company: "1. during the printing operation in the mx-16 slice console software, the clipboard used for copying and pasting images is not cleaned (erased) between patients. if the operator fails to copy the images of the current patient before pasting, the images of the previous patient may be present on the clipboard and may be copied onto the current patient's film. /// 2. during the bolus tracking scan, if the auto voice in the tracker sweep is enabled, the tracker sweep will be canceled unexpectedly and the series programmed after the sweep tracker must be started manually./// 3. if the scanning protocol with the sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed in the contrast tab of the protocol parameter area or the sas option is displayed but not enabled as preconfigured in the protocol. this problem occurs only on the first helical scan after the system initialization that applies the sas function. (the problem will not occur in the next scan if a helical scan has been performed after system startup.).

Field Classification: Field Correction through Software Update from v1.1.4.21426 to v1.1.4.21428 to correct software problems in v1.1.4.21426 /// Code of field action: FCO72800641 /// Recommendations to users and patients: Until the software is upgraded to v1.1.4.21428, follow these guidelines: Issue 1: If the copy / paste operation is used to edit patient films, check if the patient's image copied is from the current patient before you paste it into the film. Check the patient information in the image and ensure that the desired images are copied onto the film. /// Problem 2: When performing a Bolus Tracking scan, do not use the Auto Voice option in the Tracker Sweep. Use the intercom for guidance on patient breathing during the Bolus Tracking scan. /// Problem 3: If the SAS option is displayed in the Contrast tab of the scan protocol parameter area, but is not enabled, enable the SAS option manually. If the SAS option does not appear, select another series, and then select the helical scan series again. The SAS option is displayed and the operator can manually enable the SAS option. This problem can be avoided if the operator schedules the first helical scan after initializing the system without the SAS function.