Summary
The FDA issued a Class II for Omnera 400T Digital Radiographic System by Arcoma AB. Reason: 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 mo.
Details
Source
Device Recall
External ID
Z-1331-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product Description
Omnera 400T Digital Radiographic System
Lot/Code Info: UDI/DI:07350008750050; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
Quantity Affected: 71 systems
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).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-05
Company
Vaxjo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arcoma AB has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Arcoma AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arcoma AB have FDA actions?
Arcoma AB has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1331-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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