IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular informat
FDA device recall Z-1435-2011 · posted 2011-02-25 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
- Action taken
- The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that have formulas. Note: Technical Support ran diagnostic scripts for each customer and documented in GSC cases for each consignee/customer. If you have any questions, contact Agfa Healthcare at (949) 830-4959.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6 devices
- Distribution
- Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.
- Date initiated
- 2009-04-15
- Date posted
- 2011-02-25
- Date terminated
- 2011-10-13
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |