Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 A

FDA device recall Z-0649-03 · posted 2003-04-25 · Terminated

Recall details

Recalling firm

Sedecal USA, Inc.

Reason for recall

Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.

Action taken

Sedecal USA sent end user notification letters dated 9/26/02 to the consignees having the affected Sedecal X-Ray High Voltage Generators and X-Ray Controls, informing them that the units do not meet with the U.S. federal performance standards, that the labels are in Spanish and that the labels may not be visible after system installation. The accounts were told that once Sedecal has conducted performance tests on selected generators and controls to verify their compliance with the federal performance standard and analyzed that data, they will be able to complete their corrective action plan and contact the accounts with additional information. Sedecal requested the accounts to call 800-920-9525 if they had any questions, and to inform Sedecal if they sold the unit, destroyed the unit or otherwise no longer had the unit in their possession.

Root cause

Other

Status

Terminated

Product code

IZO

Quantity affected

199 units

Distribution

Nationwide, Mexico, Poland, Japan, Abu Dahbi, Venezuela, Australia, Denmark, Panama, Korea, Columbia, and Africa.

Date initiated

2002-09-26

Date posted

2003-04-25

Date terminated

2006-09-27

Location

Arlington Heights, IL