Food, drugs, devices › Philips Electronics North America Corporation
Device recall: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency w
Philips Electronics North America Corporation (Andover, MA) initiated this device recall on 22 Jul 2015; FDA lists 1 product record under event 71764, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Oct 2020. Initiation: voluntary: firm initiated. Philips Electronics North America Corporation has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Electronics North America Corporation, Andover, MA.
Reason for recall
"If arm is not fastened securely it could fall down."
Distribution
"Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0766-2016 | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. | 399 distributed, 262 are subject to this event | Class II | Terminated | 17 Feb 2016 |
Context
Other enforcement events for Philips Electronics North America Corporation
All 61 events for Philips Electronics North America Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "If arm is not fastened securely it could fall down."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Oct 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.