The Recall Desk
HighFDA (Devices)·Z-1660-2025·Announced 2025-04-30

[pending] Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Pending LLM rewrite. Source: FDA_DEVICE Z-1660-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

The recalled product

Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Manufacturer
Philips North America Llc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. 728242
  • 728243
  • 728244
  • UDI: (01)00884838098725(21)7014
  • (01)00884838098725(21)7032
  • (01)00884838059450(21)7056
  • (01)00884838098725(21)7060
  • (01)00884838098725(21)7062
  • (01)00884838098725(21)7064
  • (01)00884838098725(21)7072
  • (01)00884838098725(21)7087
  • (01)00884838059450(21)7096
  • (01)00884838059450(21)7123
  • (01)00884838059450(21)7124
  • (01)00884838098725(21)7128
  • (01)00884838098725(21)7135
  • (01)00884838098725(21)7154
  • (01)00884838098725(21)7163
  • (01)00884838098725(21)7179
  • (01)00884838098725(21)7191

Distribution

Distributed nationwide across the United States.

Related recalls

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