Z-2845-2018Class II

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Name: Z-2845-2018 DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Creator: Philips Medical Systems Gmbh, DMC
Published: 2018-06-27
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2018-06-27 / Terminated / root cause: design

FDA source

Philips Medical Systems Gmbh, DMC began a recall of DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 on 2018-06-27. FDA classified it as Class II and gives the reason as "The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient". 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-2845-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Posted: 2018-08-17
Terminated: 2024-04-30
Recalling firm: Philips Medical Systems DMC GmbH
Product: DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Root cause tag: design
FDA root cause: Device Design
Action: On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
Distribution: US Nationwide; International to 66 countries
Product codes and lots: Serial Numbers: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2845-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2841-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2842-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2843-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2844-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2845-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2846-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2847-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2848-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2849-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2850-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2851-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2852-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2853-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2854-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2855-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2856-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2857-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2858-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2859-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2860-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2861-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2862-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2863-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2864-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2865-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2866-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2867-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2868-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code MQB

K090625Class IIWireless Portable Detector Fd-W17Philips Medical Systems North America Co. / cleared 2009-03-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)