Z-2523-2020Class II

EasyDiagnost Eleva DRF, model no. 706050 -

Name: Z-2523-2020 EasyDiagnost Eleva DRF, model no. 706050 -
Creator: Philips North America, LLC
Published: 2020-06-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-06-02 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose on 2020-06-02. FDA classified it as Class II and gives the reason as "Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2523-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-02
Posted: 2020-07-10
Terminated: 2021-02-09
Recalling firm: Philips North America LLC
Product: EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm distributed Urgent Field Safety Notice letters to affected customers on 6/2/2020. Customers were informed that the thermos switches may be incorrectly installed which results in a malfunction. If the transformer overheats due to a failure and the thermos switch is not activated, the device may begin to generate smoke. Customers were advised by the firm that they can use the system according to the IFU (Instruction for Use). The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately shut down the system according to IFU or (if present) use emergency off switch in room, remove patient, stop using the system for further examinations and contact customer service. Philips plans to perform an On-Site check of the SPDU thermo contact at affected systems, which will eliminate these issues. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70600103. If you need any further information or support concerning this issue, please contact your local Philips representative.
Quantity in commerce: 52
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.
Product codes and lots: Serial Numbers SN16000004 SN17000018 SN17000020 SN17000025 SN17000026 SN18000002 SN18000004 SN18000005 SN16000002 SN16000006 SN16000011 SN16000013 SN16000017 SN16000022 SN16000025 SN16000028 SN16000029 SN16000030 SN16000031 SN16000036 SN16000037 SN16000039 SN16000041 SN16000042 SN16000043 SN16000044 SN16000045 SN16000048 SN16000054 SN16000056 SN17000001 SN17000006 SN17000008 SN17000015 SN17000017 SN17000019 SN17000021 SN17000023 SN17000027 SN17000028 SN17000029 SN17000031 SN17000032 SN17000033 SN17000034 SN17000035 SN17000036 SN17000037 SN17000038 SN18000001 SN18000003 SN18000009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2523-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2523-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07

Product code JAA

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)