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Quantum Pump Console recallZ-2238-2019 · Spectrum Medical Ltd. · initiated May 29, 2019

Class I Terminated All recalls posted in August 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spectrum Medical Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

FDA root cause category: Software design

What the company is doing

Spectrum Medical notified customers on about 05/29/2019 via "URGENT FIELD SAFETY CORRECTION" letter. Customers were informed that Spectrum Medical is in the process of installing the most recent software update v6.2.3.16 to the Quantum Perfusion Systems, (Quantum Pump Console). This software update corrects an error that could potentially lead to power loss. All Quantum Perfusion Systems are in scope of this issue. Customers were instructed to be aware that user intervention may be necessary with continued use before the software update, assure that all users receive notice of this issue, confirm receipt of the Urgent Medical Device Correction by returning the customer response form, and a Spectrum Medical service team will contact each customer and arrange a time and date to update the systems with the most recent software update. Additionally, customers were instructed to notify all relevant personnel and to customers if the devices have been further distributed.

Recall details

Recall number
Z-2238-2019
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 29, 2019
Posted by the FDA
Aug 23, 2019
Recalling firm
Spectrum Medical Ltd.
Quantity
108 units (8 US, 100 OUS)
Product code
DTQ
FDA submissions
K173834
Distribution
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.

Product description

Quantum Pump Console

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Software version 6.2.1.9; Serial Numbers PH1000005, PH1000020, PH1000027, PH1000030, PH1000077, PH1000081, PH1000082, PH1000086, PH1000087, PH1000093, PH1000100, PH1000101, PH1000102, PH1000103, PH1000109, PH1000110, PH1000112, PH1000113, PH1000114, PH1000115, PH1000120, PH1000127, PH1000129, PH1000131, PH1000132, PH1000134, PH1000135, PH1000137, PH1000139, PH1000140, PH1000141, PH1000144, PH1000145, PH1000150, PH1000156, PH1000158, PH1000159, PH1000160, PH1000161, PH1000162, PH1000165, PH1000168, PH1000170, PH1000171, PH1000172, PH1000175, PH1000176, PH1000177, PH1000178, PH1000179, PH1000180, PH1000182, PH1000201, PH1000208, PH1000209, PH1000210, PH1000211, PH1000212, PH1000213, PH1000215, PH1000233, PH1000256, PH1000257, PH1000259, PH1000438, PH1000439, PH1000440, PH1000441, PH1000442, PH1000445, PH1000455, PH1000495, PH1000498, PH1000522, PH1000615, PH1000644, PH1000645, PH1000646, PH1000647, PH1000648, PH1000649, PH1000668, PH1000669, PH1000670, PH1000682, PH1000683, PH1000684, PH1000686, PH1000687, PH1000688, PH1000689, PH1000692, PH1000722, PH1000726, PH1000727, PH1000740, PH1000742, PH1000743, PH1000744, PH1000879, PH1000880, PH1000882, PH1000885, PH1000886, PH1000895, PH1000897, PH1000939, PH1000940

Other devices under the same FDA submission

5 devices cleared under K173834 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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