Device product

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

Z-0266-2020

October 03, 2019

Class II

Product summary

Firm: Datascope Corp.
Event: Event 83927
Status: Terminated
Classification: Class II
Quantity: 7
Official record key: device-enforcement:Z-0266-2020

Official wording

Reason: One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

Code information: 10000493876

Distribution pattern: Distributed to CA, GA, and TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.