Z-1612-2008

Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48

Name: Z-1612-2008 Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
Creator: Varian Medical Systems Oncology Systems
Published: 2008-02-13
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-02-13 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48 on 2008-02-13. The reason FDA records is "A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1612-2008
Status: Terminated
Initiated: 2008-02-13
Posted: 2008-09-23
Terminated: 2011-05-17
Recalling firm: Varian Medical Systems, Inc.
Product: Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
Root cause tag: software
FDA root cause: Software design
Quantity in commerce: 90 units
Distribution: Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).
Product codes and lots: Serial numbers all starting with H48 (model number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694, 6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760, 6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870, 6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691, 6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804, 6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893, 6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707, 6686

Product code MUJ

K071873Class IIModification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. / cleared 2007-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)