CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) recalled

Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084, distributed nationwide in the US. The recall was initiated on 27 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: SN15000153 SN17000147 SN15000211 SN17000160

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2860-2018
FDA event ID: 80577
Recalling firm: Philips Medical Systems Gmbh, DMC, Hamburg
Classification: Class II
Status: Terminated
Recall initiated: 27 Jun 2018
FDA classified: 17 Aug 2018
Reported: 29 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Jun 2018	Recall initiated by company
17 Aug 2018	Classified by FDA	+51 days
29 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084

Where it was distributed

US Nationwide; International to 66 countries

Nationwide

Questions about this recall

Is DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 recalled?

Yes. Philips Medical Systems Gmbh, DMC recalled DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 on 27 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2860-2018.

Why was it recalled?

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.

Which lots are affected?

Serial Numbers: SN15000153 SN17000147 SN15000211 SN17000160

Where was it sold?

US Nationwide; International to 66 countries

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Medical Systems Gmbh, DMC

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Reported	Class	Recall	Company	Reason	Where
8 Sep 2021Device	CLASS II	CombiDiagnost R90 recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	CombiDiagnost PCF recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	CombiDiagnost GCF recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide
20 Feb 2019Device	CLASS II	Stationary Fluoroscopic X-ray System CombiDiagnost R90 recalled	Philips Medical Systems Gmbh, DMC	Other	Nationwide
31 Oct 2018Device	CLASS II	Philips DigitalDiagnost recalled by Philips Medical Systems Gmbh	Philips Medical Systems Gmbh, DMC	Device Malfunction	Nationwide

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