Recall Z-1786-2022— Micro-X Ltd.
Class II · Ongoing
Class II FDA medical device recall by Micro-X Ltd., initiated 2022-08-31. It names one FDA 510(k) clearance: K211423. Product: MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19. Reason: Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions.
- Recalling firm
- Micro-X Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-31
- Firm location
- Tonsley, N/A, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Reason for recall
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
Data sourced from openFDA. This site is unofficial and independent of the FDA.