Z-1696-2019Class II

CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI...

Name: Z-1696-2019 CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI...
Creator: Accuray Incorporated
Published: 2018-04-10
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2018-04-10 / Terminated

FDA source

Accuray Incorporated began a recall of CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010... on 2018-04-10. FDA classified it as Class II and gives the reason as "There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1696-2019
Classification: Class II
Status: Terminated
Initiated: 2018-04-10
Posted: 2019-06-01
Terminated: 2021-04-01
Recalling firm: Accuray Incorporated
Product: CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
Product code: IYE Accelerator, Linear, Medical
Reason for recall: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
FDA root cause: Other
Action: The firm issued a field safety notice by letter on 04/10/2019. The letter explained the issue and provided safety instructions. All impacted customers with affected systems will be contacted to arrange for a software upgrade.
Quantity in commerce: 68 units
Distribution: US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
Product codes and lots: a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C0444, C0445, C0446, C0447, C0448, C0449, C0450, C0453, C0454, C0456, C0457, C0458, C0460, C0464, C0465, C0466, C0472, C0475 b) 053101-010: CyberKnife M6 FI Treatment Delivery System Serial Numbers: C0334, C0381 c) 053201-010: CyberKnife M6 FM Treatment Delivery System Serial Numbers: C0363 d) 053301-010: CyberKnife M6 FIM Treatment Delivery System Serial Numbers: C0337, C0343, C0349, C0352, C0358, C0370, C0371, C0378, C0384, C0387, C0389, C0390, C0391, C0393, C0409, C0424, C0426, C0427, C0428, C0433, C0439 e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System Serial Numbers: C0330, C0332, C0342, C0344, C0345, C0348, C0359, C0360, C0364, C0367, C0372, C0394, C0398, C0400, C0402, C0404, C0415, C0419 f) 053501-010: CyberKnife Matrix Tier F TDS Serial Numbers: C0396

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1696-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1697-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31

Product code IYE

K150873Class IICyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemAccuray Incorporated / cleared 2015-07-01

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)