Z-0152-2015Class II

Laksell Gamma Knife Perfexion

Name: Z-0152-2015 Laksell Gamma Knife Perfexion
Creator: Elekta, Inc.
Published: 2014-10-06
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-10-06 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Laksell Gamma Knife Perfexion on 2014-10-06. FDA classified it as Class II and gives the reason as "Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0152-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-10-30
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: Laksell Gamma Knife Perfexion
Product code: IWB System, Radiation Therapy, Radionuclide
Reason for recall: Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.
Root cause tag: design
FDA root cause: Device Design
Action: Elekta sent an" Important Field Safety Notice" distributed on October 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Important Field Safety Notice describes the problem and possible work arounds for customers to follow until a permanent solution can be developed. They are: " Always assure that the plastic lever is only operated when at a right angle with the frame adapter. " Do not force the plastic lever in place if it meets significant resistance when turned. " Ensure that the plastic lever is completely flush with the frame adapter and that no angulations are present. Corrective Action #2 - Elekta will check and replace as necessary affected frame adapters in the field. This will be released at the end of October 2014, and Elekta will have six months to complete the checks and replacements for those products in the field. If you have any questions please contact your local Elekta office, or call (770) 300-9725.
Quantity in commerce: 181
Distribution: Worldwide Distribution - USA (nationwide) including the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OR, PA, RI, SC, TX, TN, UT, VA, WA and WV, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Mexico, Morocco, Netherland, Norway, Poland, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Product codes and lots: Serial No. 6052, 6144, 6088, 6122, 6158, 6005, 6028, 6097, 6153, 6064, 6081, 6103, 6120, 6143, 6145, 6213, 6215, 6076, 6070, 6136, 6002, 6090, 6131, 6063, 6160, 6077, 6018, 6031, 6040, 6105, 6121, 6013, 6026, 6038, 6050, 6089, 6042, 6055, 6058, 6071, 6080, 6087, 6091, 6096, 9098, 6106, 6108, 6109, 6116, 6118, 6125, 6132, 6133, 6142, 6148, 6149, 6161, 6162, 6175, 6181, 6183, 6198, 6205, 6206, 6163, 6169, 6033, 6041, 6046, 6068, 6113, 6019, 6067, 6110, 6104, 6043, 6044, 6062, 6085, 6086, 6101, 6111, 6123, 6126, 6157, 6177, 6178, 6024, 6069, 6094, 6007, 6075, 6182, 6065, 6159, 6199, 6003, 6017, 6027, 6039, 6112, 6146, 6194, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6053, 6054, 6056, 6057, 6060, 6061, 6066, 6072, 6073, 6074, 6078, 6079, 6082, 6083, 6084, 6092, 6093, 6095, 6099, 6100, 6102, 6107, 6114, 6115, 6117, 6119, 6124, 6127, 6128, 6129, 6130, 6134, 6135, 6139, 6141, 6150, 6151, 6165, 6167, 6171, 6172, 6173, 6176, 6179, 6180, 6184, 6185, 6191, 6192, 6200, 6203, 6207, 6211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0152-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-30

Product code IWB

K120811Class IILeksell Gamma Knife PerfexionElekta Instrument AB / cleared 2012-05-24

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)