Elekta, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2405-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Precise Digital Accelerator Delivery of radiation to defined target volumes

Product Classification:

Class II

Date Initiated: August 6, 2012

Date Posted: September 26, 2012

Recall Number: Z-2405-2012

Event ID: 62917

Reason for Recall:

There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Status: Terminated

Product Quantity: 110

Code Information:

151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073

Distribution Pattern:

Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto

Voluntary or Mandated:

Voluntary: Firm initiated