Home / Recalls / Philips North America, LLC / Z-1806-2020

Z-1806-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 6, 2020
Initiation Date
April 7, 2020
Termination Date
April 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
346 units (5 US and 341 OUS)

Product Description

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Reason for Recall

If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.

Code Information

All serial numbers

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  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
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  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)