CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report

Patient Support Material Number: 9890 010 87431 used recalled

Philips Medical Systems is recalling Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost, distributed in 11 states. The recall was initiated on 19 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll patient support for stitching are affected.

Quantity recalled1517 systems, not all units have the patient support accessory

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-0364-2016
FDA event ID: 69090
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2014
FDA classified: 3 Dec 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

19 Aug 2014	Recall initiated by company
3 Dec 2015	Classified by FDA	+471 days
9 Dec 2015	Published in enforcement report	+6 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 vertical position. Therefore the footplate can fall or swing down and may hurt the 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

Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

Where it was distributed

Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.

Arizona Connecticut Florida Hawaii Kentucky Massachusetts Minnesota North Carolina Texas Virginia Wyoming

Questions about this recall

Why was it recalled?

The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

Which lots are affected?

All patient support for stitching are affected.

Where was it sold?

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

Other products in this recall event

1 other product · FDA event 69090

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015	CLASS II	Patient Support Material Number recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	11 states

More recalls from Philips Medical Systems

All 82

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	IQon Spectral CT IQon Spectral CT Upgrades recalled	Philips Medical Systems	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	Philips Spectral CT on Rails recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide