Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
FDA device recall Z-1079-06 · posted 2006-06-03 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
- Action taken
- Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions (MPR''s). According to the Device Correction Notice, a software upgrade has already been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006, and this software upgrade 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
- 16
- Distribution
- The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
- Date initiated
- 2006-02-21
- Date posted
- 2006-06-03
- Date terminated
- 2008-11-13
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCEPTREP3 PET/CT (K042428) | Hitachi Medical Systems America, Inc. | 2004-09-17 |
| HITACHI PRESTO (K040902) | Hitachi Medical Systems America, Inc. | 2004-04-21 |