ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) is a modular, integrated syste

FDA device recall Z-1651-2013 · posted 2013-07-02 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

Action taken

Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letters dated May 6, 2013 and response forms to all affected customers. Ortho Clinical Diagnostics informed their customers of the issue and advised if they detect the smell of melting plastic or observe smoke originating from your VITROS System, to immediately power down the system and contact OCD for assistance. They were also advised to consider performing the backup procedure more frequently to help prevent the loss of data on their Systems. In the near future, an OCD Field Engineer will contact customers who are affected and perform a Modification (MOD) procedure that will replace their potentially affected Wire Connector(s). Foreign affiliates were informed by email on May 6, 2013 of the issue and instructed to notify their customers of the issue and actions. OCD also found that this wire connector is commonly used in many types of computers (i.e., medical devices, personal computers, etc.). On 29 May 2013, OCD expanded their recall to incllude ORTHO Assay Software (OAS) Servers. As a precaution, OCD sent notifications to encompass all ORTHO Assay Software (OAS) Servers that potentially contain this type of wire connector. The letters (Ref. CL13-154) were sent via US Priority Mail to all customers who were shipped an affected OAS Server. Ortho Clinical Diagnostics has requested that customers with any questions or in need of additional information, please call Customer Technical Services at 1-800-421-3311.

Root cause

Device Design

Status

Terminated

Product code

MZA

Quantity affected

31 units

Distribution

Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN,

Date initiated

2013-05-06

Date posted

2013-07-02

Date terminated

2018-05-16

Location

Rochester, NY