Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)

FDA device recall Z-1078-06 · posted 2006-06-03 · Terminated

Recall details

Recalling firm

Hitachi Medical Systems America Inc

Reason for recall

The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.

Action taken

Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.

Root cause

Other

Status

Terminated

Product code

JAK

Quantity affected

15 units

Distribution

The recalled MRI systems were distributed throughout the continental United States.

Date initiated

2006-02-21

Date posted

2006-06-03

Date terminated

2008-11-13

Location

Twinsburg, OH

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