Z-3191-2018Class II

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Name: Z-3191-2018 ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Creator: Swissray Medical
Published: 2016-11-18
License: https://open.fda.gov/license/

SWISSRAY Medical, AG / initiated 2016-11-18 / Open, Classified / root cause: design

FDA source

Swissray Medical began a recall of ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging on 2016-11-18. FDA classified it as Class II and gives the reason as "Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3191-2018
Classification: Class II
Status: Open, Classified
Initiated: 2016-11-18
Posted: 2018-09-18
Recalling firm: SWISSRAY Medical, AG
Product: ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Product code: KPR System, X-Ray, Stationary
Reason for recall: Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Swissray Medical, issued official communication to customers as a Action Notification Report/work Instructions on November 18 2016. The Work Instructions state the affected devices, the problem symptoms, causes of the problem, remedy, any tools required, and the step-by-step corrective actions. The manufacturer, Swissray Medical AG, distributed the Work Instructions for the FCO and the Action Notification Report Form to all distributors and service entities who would be performing corrective actions in the field. The Swissray Field Engineer then presented the Report to the customer (end user facility) and communicated with the customer in-person while performing the corrective action on-site. When corrective actions were completed, both the customer and service personnel then sign the Report to confirm that the customer was informed about the corrective action and that corrective action was completed. The Report Form states the title and unique designation of the corrective action, whether it was mandatory by the manufacturer or was an optional product improvement, and the unique document ID number of the Work Instructions for the FCO. The customers were instructed to Complete the FCO Action Notification Report and send to: Swissray Medical AG expert Center Turbistrasse 25-27 CH-6280 Hochdorf Switzerland Or scan and email to [email protected] with FCO in the subject line. If you have any questions, contact QA/RA Coordinator at 908-372-6408 or email: [email protected].
Quantity in commerce: 27 devices in US
Distribution: Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
Product codes and lots: Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008 & 1602004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3191-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3191-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code KPR

K052943Class IIDdrformula and Ddrformula PlusSwissray Medical AG / cleared 2005-12-15

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)