FDA Device Recall Z-0018-05: Datascope Corp

Recall Res Number

Z-0018-05

Recalling Firm / Manufacturer

Datascope Corp

FEI Number

2221819

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-24

Date Posted

2004-10-13

Date Terminated

2005-09-15

Product Code

NWI

Event Number

30145

Product Quantity

19

Product Description Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

Reason for Recall Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.

Action Details Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.

Distribution Pattern Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.

Code Information / Serial Numbers Serial Number: MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.

Sterigenics U.S., LLC Registration: 1061124 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
UNITED STATES ENDOSCOPY GROUP, INC. Registration: 1528319 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
MARK ENTERPRISES Registration: 3002821232 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
Cardinal Health 200, LLC Registration: 3007329020 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
Highridge Medical, LLC Registration: 3012447612 View Registration
Olive Branch Distribution Center Registration: 3016050940 View Registration
MARKEN HEALTHTECH LIMITED Registration: 3042989733 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration

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Medical Device Recall: Z-0018-05

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