ModerateClass IITerminated

FDA Devices recall · Reported January 23, 2019

MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0745-2019.

Q: Where was the recalled product distributed?

Distribution: The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Cote D'Ivoire, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greenland, Guam, Vatican City State, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Monaco, Mongolia, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Reunion, Russian Federation, Saint Pierre and Miquelon, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey UAE, UK, Uruguay, Venezuela, Vietnam..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become l…

Recall #: Z-0745-2019
Affected scope: 16656
Initiated: December 14, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Bayer Medical Care, Inc. recalled MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with t… - a moderate-severity action.

MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with t… was recalled by Bayer Medical Care, Inc. in January 23, 2019. Reason: If the head mount knob is not properly tightened and the operator directly uses the injector head to move the…. Check the official notice for the remedy. Verify recall #Z-0745-2019 with the FDA Devices before acting.

The recall

Bayer Medical Care, Inc. issued this moderate-severity FDA Devices recall-If the head mount knob is not properly tightened and the operator directly uses the injector head to move the….

Moderate
severity level: 17K units
affected scope: Class II
classification: January 23, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0745-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700

Reason for recall

If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0745-2019
Date reported	January 23, 2019
Date initiated	December 14, 2018
Recalling firm	Bayer Medical Care, Inc.
Firm location	Indianola, PA
Affected scope	16656
Distribution	The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

16656 units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0745-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0745-2019.

Where was the recalled product distributed? ▼

Distribution: The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Cote D'Ivoire, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greenland, Guam, Vatican City State, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Monaco, Mongolia, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Reunion, Russian Federation, Saint Pierre and Miquelon, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey UAE, UK, Uruguay, Venezuela, Vietnam..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported January 23, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026