| Date Initiated by Firm | May 05, 2021 |
|---|
| Create Date | June 14, 2021 |
|---|
| Recall Status1 |
Terminated 3 on June 18, 2024 |
| Recall Number | Z-1855-2021 |
|---|
| Recall Event ID |
87904 |
| 510(K)Number | K210392 |
|---|
| Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
| Product | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 |
|---|
| Code Information |
None |
Recalling Firm/
Manufacturer |
Abbott Laboratories Inc. (St Jude Medical)
1 Saint Jude Medical Dr
Saint Paul MN 55117-1789
|
| For Additional Information Contact | Mr. Justin Paquette
651-756-6293 |
|---|
Manufacturer Reason
for Recall | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
|---|
FDA Determined
Cause 2 | Software Manufacturing/Software Deployment |
|---|
| Action | Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient. |
|---|
| Quantity in Commerce | 8 units |
|---|
| Distribution | US Nationwide distribution in the states of MI, KS, MO, 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 = DQK
|
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