Date Initiated by Firm |
December 09, 2019 |
Create Date |
January 30, 2020 |
Recall Status1 |
Terminated 3 on September 17, 2020 |
Recall Number |
Z-0921-2020 |
Recall Event ID |
84497 |
510(K)Number |
K160370
|
Product Classification |
Electrode, ion specific, sodium - Product Code JGS
|
Product |
ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring)) |
Code Information |
Serial Numbers W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T |
Recalling Firm/ Manufacturer |
Mindray DS USA, Inc. dba Mindray North America 800 Macarthur Blvd Mahwah NJ 07430-2001
|
For Additional Information Contact |
Diane Arpino 201-995-8407
|
Manufacturer Reason for Recall |
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The consignee notification was sent certified mail with return receipt verification. The letter identified the affected product, problem and actions to be taken by the Customer/User. Customers were instructed to:
Continue to use the system normally and exercise caution when lifting/closing the front and rear cover. Attachment A includes a list of system(s) identified by model and serial number purchased by your company. We recommend that you notify the clients to which you have distributed these systems and advise them to continue normal use with the recommended caution.
The gas springs on the systems listed in Attachment A will require replacement and instructions are provided in Attachment B. The parts needed to perform the replacement will be shipped to you within the next several weeks.
Type of Action by the Company
Mindray will provide replacement gas springs at no cost. Should you require technical assistance while preforming the replacement, please contact Mindrays Technical Support team at 800-288-2121, option 2 (Technical Support), then choose option 3 (IVD Support team). |
Quantity in Commerce |
6 |
Distribution |
The products were distributed to the following US states: MI and TX. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JGS and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
|