Z-1332-2022Class II

Omnera 400A Digital Radiographic System

Name: Z-1332-2022 Omnera 400A Digital Radiographic System
Creator: Arcoma AB
Published: 2021-05-05
License: https://open.fda.gov/license/

Arcoma AB / initiated 2021-05-05 / Open, Classified / root cause: design

FDA source

Arcoma AB began a recall of Omnera 400A Digital Radiographic System on 2021-05-05. FDA classified it as Class II and gives the reason as "There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1332-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-05
Posted: 2022-07-05
Recalling firm: Arcoma AB
Product: Omnera 400A Digital Radiographic System
Product code: KPR System, X-Ray, Stationary
Reason for recall: There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
Root cause tag: design
FDA root cause: Device Design
Action: On May 7, 2021, Arcoma issued a "Urgent Field Safety Notice". The recall notice asked consignees to take the following actions: Identify the device Take note of amendment/reinforcement of Instructions of Use (IFU) and replace all pages in the Cleaning and disinfection chapter with pages in FSN_2021_01_IFU-EN Rev. 1.1. On May 23, 2022, Arcoma issued a Safety Advisory Notice/ Field Safety Notice via E-Mail informing consignees that they would be updating the display handle with the updated version as an additional safety precaution. Arcoma has requested that Canon Medical System, USA ensure that all those who have the affected product, including any others who may need to be informed, receive the safety relevant information provided with this notice and comply with the recommendations herein. A representative of Canon Medical System USA will contact you to schedule a time to replace the display handle with the updated version.
Quantity in commerce: 47 systems
Distribution: US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada.
Product codes and lots: UDI/DI: 07350008750012; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1332-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1331-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-05
Z-1332-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-05

Product code KPR

K140683Class II0180 Intuition, 0072 PrecisionArcoma AB / cleared 2014-06-03

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)