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Recall Observatory FDA recall evidence

Device product

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Z-2523-2020

June 02, 2020

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 85810
Status
Terminated
Classification
Class II
Quantity
52
Official record key
device-enforcement:Z-2523-2020

Official wording

Reason: Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.