Devices

Device Recall CIVCO SBRT System, REF MTSBRT001,

Model / Serial
M061240, M061420, M064140, M064150, M064160, M064170, M064180, M064190, M064200, M064210, M064220, M064230, M070640, M070650, M070660, M072030, M104700, M104710, M104720, M104740, M110410, M110420, M110450, M110460, M115610, M128630, M128660, M128680, M128690, M137590, M148640, M148660, M148690, M148700, M165740, M177850, M177880, M226800, M226810, M226820, M226830, M226840, M239320, M239330 and M256660
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
Product Description
CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa || Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
Manufacturer
Civco Medical Instruments Inc
1 Event
- Recall of Device Recall CIVCO SBRT System, REF MTSBRT001,

Manufacturer

Civco Medical Instruments Inc

Manufacturer Address
Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
Manufacturer Parent Company (2017)
Roper Technologies Inc
Source
USFDA

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