| Class 2 Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), | |
Date Initiated by Firm | March 30, 2015 |
Date Posted | May 02, 2017 |
Recall Status1 |
Terminated 3 on May 05, 2017 |
Recall Number | Z-1923-2017 |
Recall Event ID |
76946 |
510(K)Number | K082421 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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Product | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system. |
Code Information |
ISA CO2 Sensor serial numbers: 107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435, 107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776, 107831, 107832, 107836, 107839, and 107841. |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact | Merge Service and Support 877-741-5369 |
Manufacturer Reason for Recall | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script.
The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they have the affected ISA CO2 sensors at their facility and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. For further questions, please call (877) 741-5369. |
Quantity in Commerce | 23 sensors (PhaseIn Units) |
Distribution | US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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