Z-0842-2018Class II

INFX-8000F Fluoroscopic X-Ray Systems

Name: Z-0842-2018 INFX-8000F Fluoroscopic X-Ray Systems
Creator: Toshiba American Medical Systems Inc
Published: 2017-12-29
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-12-29 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of INFX-8000F Fluoroscopic X-Ray Systems on 2017-12-29. FDA classified it as Class II and gives the reason as "During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0842-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-29
Posted: 2018-03-02
Terminated: 2023-11-29
Recalling firm: Canon Medical Systems USA, Inc.
Product: INFX-8000F Fluoroscopic X-Ray Systems
Product code: MBQ Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
Reason for recall: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.
Quantity in commerce: 17 units
Distribution: United States
Product codes and lots: Serial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0842-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0842-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0843-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0844-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0845-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code MBQ

K081624Class IIInfx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C / cleared 2008-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)