Omnera 400T Digital Radiographic System
FDA device recall Z-1331-2022 · posted 2022-07-05 · Open, Classified
Recall details
- Recalling firm
- Arcoma AB
- 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).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 71 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.
- Date initiated
- 2021-05-05
- Date posted
- 2022-07-05
- Location
- Vaxjo, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0180 INTUITION, 0072 PRECISION (K140683) | Arcoma AB | 2014-06-03 |