Z-2128-2020Class II

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Name: Z-2128-2020 Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-04-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-04-17 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194 on 2020-04-17. FDA classified it as Class II and gives the reason as "The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other...". 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-2128-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-17
Posted: 2020-05-04
Terminated: 2020-08-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
Root cause tag: design
FDA root cause: Device Design
Action: URGENT: MEDICAL DEVICE CORRECTION notification letters dated 4/17/20 were sent to customers. What is the impact to the operation of the system and what are the possible risks? There is no impact to the operation of the system, however, unplugging the main cable can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector which can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. How was the subject identified and what is the root cause? The issue was identified by the manufacturer during system assembly when the plug of the main cable was unplugged. The root cause is a design flaw in a generator component of the generator Polydoros M25 revision 04. What actions do we recommend urgently to mitigate possible risks? We strongly recommend that you do not unplug the main cable until the generator is repaired by a service engineer. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the hardware error via Update Instruction AX028/20/S in which a Siemens Service Engineer will repair the generator at your site. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.
Quantity in commerce: 20
Distribution: US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.
Product codes and lots: Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2128-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2127-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2128-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code OWB

K181550Class IICios SpinSiemens Medical Solutions USA, Inc. / cleared 2018-10-30

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)