FDA Device recall Z-2384-2012
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications by Philips Healthcare, citing creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2384-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-14 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | OH, WA |
Product
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Reason
Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
Identifiers
| code_info | Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Philips Healthcare
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FDA Device · Class II · 2022-04-13 · Philips Healthcare - Azurion systems with software release R2.0.x
FDA Device · Class II · 2022-03-30 · Philips Healthcare - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2384-2012%22
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