Carl Zeiss Meditec recalls 155 PLEX Elite 9000 Swept-Source OCT devices due to potential hazardous voltage exposure when contacting metal parts near the up/down switch during use.
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
Carl Zeiss Meditec is recalling 155 specific models of the PLEX Elite 9000 Swept-Source OCT device because faulty design could expose users to hazardous voltage when touching metal parts around the up/down switch. This poses a risk of electric shock during normal operation.
The device's design may allow hazardous voltage to be exposed when the operator touches metal components near the up/down switch during normal use. This could cause electric shock if the device is faulty.
Ophthalmologists and medical professionals who use the PLEX Elite 9000 Swept-Source OCT device for eye imaging are most at risk. The recall affects specific serial numbers from PE9000-001 to PE9000-0158.
Check for serial numbers starting with PE9000-001 through PE9000-0158 on the device's label. The PLEX Elite 9000 Swept-Source OCT is used for detailed eye imaging in medical settings.
Look for the serial number on the device label to confirm if it's in the affected range (PE9000-001 to PE9000-0158).
If your device has a serial number in the affected range, stop using it immediately to avoid potential electric shock.
The device may expose users to hazardous voltage when touching metal parts near the up/down switch during normal use, which could cause electric shock.
155 specific models with serial numbers from PE9000-001 to PE9000-0158 are affected.
Stop using it immediately and check the serial number to confirm if it's in the affected range.
We’ve drafted a message you can send Carl Zeiss Meditec to request your refund or repair — edit it as you like.
Subject: Recall Z-0770-2020 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-0770-2020 from Carl Zeiss Meditec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
