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Recall Observatory FDA recall evidence

Device product

Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.

Z-0372-2017

September 27, 2016

Class II

Product summary

Firm
Schaerer Medical USA Inc
Event
Event 75288
Status
Terminated
Classification
Class II
Quantity
10 replacement cylinders.
Official record key
device-enforcement:Z-0372-2017

Official wording

Reason: The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.

Code information: Lot code of the replacement cylinders, 2016-02-01

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.