Pro-Med recalls DORO LUCENT Locking Transitional Member (serial numbers listed) due to potential headrest system failure during surgery. Affected users should contact Pro-Med for details.
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
Pro-Med is recalling a specific locking transitional member used in surgical headrest systems. This component, when combined with certain design revisions, could malfunction and fail during procedures, risking patient safety.
The hazard arises when two different design revisions of the base unit, locking transitional member, and transitional member are used together in one set. This combination can cause the headrest system to malfunction or fail during surgery, potentially compromising patient safety.
Surgical teams using the DORO LUCENT headrest system with the recalled transitional member (serial numbers listed) are affected. Patients undergoing open or percutaneous craniotomies or spinal surgeries are at risk if the system fails.
Check if your surgical headrest system includes the DORO LUCENT Locking Transitional Member with serial numbers listed in the recall notice (e.g., 1704002, 1704004, etc.).
Identify if your DORO LUCENT Locking Transitional Member has a serial number from the list provided in the recall notice.
The combination of two different design revisions of the DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
The recall notice does not specify a remedy; you should contact Pro-Med Instruments directly for further instructions.
The recall states that the combination of design revisions could cause the headrest system to malfunction or fail during surgery, which may pose a risk to patient safety.
We’ve drafted a message you can send Pro-Med Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-2971-2018 — Pro-Med Instruments Pro-Med Instruments Hello, I own a Pro-Med Instruments that is covered by recall Z-2971-2018 from Pro-Med Instruments. 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.
