Recall Z-0437-2024— Carestream Health, Inc.
Class II · Ongoing
Class II FDA medical device recall by Carestream Health, Inc., initiated 2023-10-02. It names one FDA 510(k) clearance: K191025. Product: DRX Revolution Mobile X-Ray System. Reason: Unexpected failure of electrical components within the CPI generator..
- Recalling firm
- Carestream Health, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-02
- Firm location
- Rochester, NY, United States
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
DRX Revolution Mobile X-Ray System
Reason for recall
Unexpected failure of electrical components within the CPI generator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.