4 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
FDA Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics Tapered ABS MicroTip" 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy TurboSonics Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code NKX·May 3, 2013
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013