Z-2855-2018Class II

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Name: Z-2855-2018 DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
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 4.1 High Performance (Stitching Patient Support) 712031 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-2855-2018
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 4.1 High Performance (Stitching Patient Support) 712031
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: SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2855-2018
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)