Reported Sep 26, 2018 · Terminated
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments GmbH
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pro-Med Instruments Gmbh · Botzinger Str. 38 · Freiburg Im Breisgau, N/A · N/A
Is this the product you have?
- DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
- Lot codes and dates
- Serial Numbers
170400217040041704005170400717040111704041170401017040191704012170401417040161704017170402117040241704025170403617040381704018170400817040341704026170402717040281704029170403017040321704035170400617040371704039
- Serial Numbers
- Amount recalled
- 30 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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