Z-3248-2018Class II

ddR Formula B X-ray System, ddR Formula B

Name: Z-3248-2018 ddR Formula B X-ray System, ddR Formula B
Creator: Swissray Medical
Published: 2016-08-09
License: https://open.fda.gov/license/

SWISSRAY Medical, AG / initiated 2016-08-09 / Open, Classified / root cause: design

FDA source

Swissray Medical began a recall of ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging on 2016-08-09. FDA classified it as Class II and gives the reason as "Possible injury due to movement of the arm, calibration loss and communication loss". 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-3248-2018
Classification: Class II
Status: Open, Classified
Initiated: 2016-08-09
Posted: 2018-09-25
Recalling firm: SWISSRAY Medical, AG
Product: ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Product code: KPR System, X-Ray, Stationary
Reason for recall: Possible injury due to movement of the arm, calibration loss and communication loss.
Root cause tag: design
FDA root cause: Device Design
Action: November 2016, Swissray Medical issued official communication to customers as a Action Notification Report. 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.
Quantity in commerce: 26 units
Distribution: US Nationwide
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, 1702001, 1702002, 1702003 & 1702004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3248-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3248-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-10-03	2018-09-25

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)