Z-1679-2020Class II

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus...

Name: Z-1679-2020 ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-02-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-02-18 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console... on 2020-02-18. FDA classified it as Class II and gives the reason as "Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1679-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-18
Posted: 2020-04-07
Terminated: 2021-02-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
FDA root cause: Use error
Action: A Customer Safety Advisory Notice was sent to all affected consignees on 2/18/2020 via Adobe Mega Sign or USPS certified mail. The notice describes the interlock scenarios, provides user instructions, and warns the user of potential risks. The interlock scenarios are as follows: MONITOR 2: Monitor 2 total dose coincidence. Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment. TREATMENT TIME: Preset treatment time coincidence with actual treatment time. Intent: This interlock is intended to prevent overdose if preset treatment time is exceeded. MONITOR SYNC (SW): Excessive accumulated dose deviation detected between the primary and the secondary dose monitoring systems. Intent: This interlock is intended to prevent patient mistreatment due to the inaccurate monitoring of delivered dose. When one or more of the above described interlocks occur, it may be assumed that there is an error in the dose monitor system.The Consumer Safety Advisory Notice states that the Operator's Manual Instructions Update document should be added to the product's manual and all users should be informed of the issues.
Quantity in commerce: 1012
Distribution: Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming
Product codes and lots: Serial Numbers 3905, 70-4077, 4082, 70-4283, 70-4368, 5177, 3922, 5120, 5170, 5179, 5205, 5226, 5245, 5282, 5300, 5343, 5385, 5391, 5506, 5665, 4078, 70-4143, 70-4235, 70-4296, 70-4344, 5154, 5281, 5417, 3755, 3761, 3802, 3801, 3901, 3981, 4072, 70-4174, 70-4354, 70-4378, 5087, 5088, 5096, 5095, 5098, 5118, 5148, 5396, 5157, 5821

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-07
Z-1678-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-07
Z-1679-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-07
Z-1680-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-07

Product code IYE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)