Civco Medical Instruments Inc

Lot#'s: M551490 and M550150

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. || Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570

Radiology Devices

2

No

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. || Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

Lots M615880, M598520, M591150, and M581180.

Radiology Devices

2

No

Nationwide Distribution -- WA, CA, and MO.

CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.

M105110, M108810, M109210, M110470, M110500, M110510, M115630, M128700, M128710, M128720, M137600, M137610, M148780, M148790, M148800, M177910, M177920, M177930, M177940, M177950, M177960, M196700, M196710, M196720, M200120, M200130, M200140, M226740, M226750, M226780, M228640, M230110, M239340, M239350, M245100 and M258280

Radiology Devices

2

No

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.

CIVCO SBRT System, REF MTSBRT001L, 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.

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

Radiology Devices

2

No

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.

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.