Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Reported: May 15, 2024 Initiated: April 17, 2024 #Z-1784-2024
Product Description
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Reason for Recall
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
Details
- Recalling Firm
- NRT X-RAY A/S
- Units Affected
- 35
- Distribution
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
- Location
- Hasselager, N/A
Frequently Asked Questions
What product was recalled? ▼
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system. Recalled by NRT X-RAY A/S. Units affected: 35.
Why was this product recalled? ▼
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Moderate. Recall number: Z-1784-2024.
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